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Iso 13485 certified - Import export

82 Companies

4 Products

PRODUCTION IN TIME ZERSPANTECHNIK UND HANDELS GMBH

Germany

PIT means Production In Time and stands for quality-conscious just-in-time production in the CNC turning industry. PIT produces absolute high-end precision and items only leave our factory if they can meet this standard. PIT GmbH is one of the smaller SME companies in this industry that have been successfully certified to ISO 9001, IATF 16949 and ISO 13485. Feasibility analysis: This important tool is the cornerstone for every single project that starts in our company. Precise piece time calculation: The determination of cycle times influences the process cycle immensely. A professional approach involving the expertise of experienced employees is a matter of course for us. Detailed and fair calculation: Direct and open communications with suppliers as well as customers should not be neglected in pricing. We have been successfully working with various suppliers of raw materials and tools for years and feel their trust. Offer development: The use of professional “requirements engineering” is the basis for the preparation of an offer. No offer leaves our company before it has been personally coordinated with our customers. Project planning & Development: With the application of the APQP process, we steer our projects to success in a targeted manner. The individual milestones are closely tracked and always completed with professional dedication.

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PROGRESS SILICONES

France

PROGRESS SILICONES has been specialised in the manufacture of silicone parts and other elastomers for industry and the medical sector since 1985. PROGRESS SILICONES designs, manufactures and sells silicone parts for the most demanding industries. Sectors, such as: the food industry, nuclear power, cosmetics, aeronautics, pharmaceuticals and biomedical. From single parts to mass production, we create all types of moulded parts, overmoulding, extrusion, co-extrusion, manufacturing and cutting. All our production can be associated with specific marking and packing operations, according to your specifications. We are equipped with 2 Clean Rooms covering 550 m2 classed ISO 7 and ISO 8, adapted to the manufacture of medical and pharmaceutical products. Our quality management system is ISO 9001 and ISO 13485 certified.

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WESTLAKE PLASTICS EUROPE

France

Westlake Plastics is one of the world's leading manufacturers of extruded and compression moulded high-performance semi-finished thermoplastic polymer products. We convert a full range of thermoplastic resins into bars, slabs and films. These semi-finished products are used in the medical devices, defence, aeronautics, food processing, biopharmaceutical and other industries. Westlake Plastics Europe is an ISO 9001: 2015- and ISO 13485: 2016-certified company.

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CORIS BIOCONCEPT

Belgium

Coris Bioconcept, founded in 1996 and ISO 13485-certified, manufactures high-tech diagnostic kits for the biomedical sector (for detecting viruses responsible for digestive and respiratory conditions, immunochromatographic testing for fast detection of CPE and OXA-48, etc.). Coris Bioconcept specializes in physical and natural science research and development for the pharmaceutical industry.

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HYB D.O.O.

Slovenia

We have five decades of globally recognized experience in the production of thick-film hybrid circuits, pressure sensors, custom-made products and medical devices. We provide a full range of services covering processes from development to series production to create custom products based on our customer’s needs. The hybrid technology used in the HYB manufacturing process combines different technologies with the aim of producing high-quality and powerful pressure sensors. We offer customized solutions from minor modifications of standard hybysens® branded products to the development of completely new pressure sensors based on customer requirements. The medical program is the result of long-term development and stems from many years of experience in pressure sensor production. The most extensive is the invasive blood pressure measurement program, trademarked hybymed® and standalone components which are also available for further installation. An ISO 13485 certified and maintained quality management system and proper production in clean room (Class 8 by ISO 14644-1) guarantee the high and consistent quality of our products. All hybymed® products are CE certified. The operation of the company is coordinated with the quality standards ISO 9001, ISO 13485 and ISO 14001 and the requirements of medical regulation. We present our innovative solutions to the public and as recipients of numerous awards we are proud to be among the most innovative Slovenian companies.

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EUROGENTEC

Belgium

Eurogentec S.A., part of Kaneka Corporation, is a leading supplier of specialty products and custom services. Our Life Science Research, Diagnostic services and GMP BioManufacturing Business Units provide high quality products to support scientists involved in the Life Science Research, biotechnology, diagnostic and pharmaceutical markets. Eurogentec is fully ISO 9001, ISO 13485 certified, cGMP accredited by the Belgian Ministry of Health and approved by the US FDA for the commercial manufacturing of a biologic for the US market. The Life Science Research BU provides trusted reagents and services for Genomics and Proteomics. The Eurogentec's Diagnostic Services Business Unit guarantees high quality GMP components dedicated for diagnostic applications. As a GMP accredited manufacturer of parenteral biologics since 1994, Eurogentec's GMP Biomanufacturing Business Unit develops and produces material for clinical trials and commercialization.
PPS P.E.T. PACKAGING SOLUTION AG

Switzerland

You need the best packaging for food, beverages, detergents, cosmetics, pharmaceuticals etc.? PPS offers you a wide range of attractive jars and bottles covering all services from the development of the body design up to the suitable closure. We are a middle-sized, privately owned company, consistently building upon the advantages offered through this unique position. Our future success, and the success of our current brands is based upon a long-standing tradition and extensive experience. As well as quality, flexibility is one of our greatest strengths. We are a solution-orientated business, keeping our focus on the problems at hand at all times. We are pragmatic and partner orientated, putting business objectives before personal profiling. We are EN ISO 9001 and EN ISO 13485: 2003 certified.
SHP STERILTECHNIK AG

Germany

SHP Steriltechnik AG is an established company in the field of steam sterilisation equipment for more than 14 years. The Laboklav autoclave series is available to the customer according to their individual requirements and dimensions. A manufacturer's warranty of up to five years and numerous accessories as well as a range of spare parts round off the service spectrum. Investments in research, development and marketing led to product development in the medical sector. All products are ISO DIN 9001: 2015 and ISO DIN 13485 certified and TÜV tested. In 2020, the company received an award in 2020 for being the best German manufacturer of steam sterilisers. Memberships exist with the SPECTARIS association. Professional Association of Analysis, Bio- and Laboratory Technology and the Association of Wholesale and Foreign Trade in Nursing and Laboratory Supplies. The SHP Steriltechnik AG group also includes two companies that stand for sustainability, recycling and environment.
XYZTEC

Netherlands

XYZTEC, incorporated in 2000, designs and manufactures innovative equipment that is used for quality assurance to ensure the reliability of many products in multiple industries. We set the standard in Statistical Process Control (SPC). We are 100% focused on bond testing and have established our name as technology leader in bond testing worldwide. Our equipment is used in semiconductor, automotive and raw material industry. XYZTEC is committed to working with various research institutes and universities globally. Customer satisfaction, high quality, innovation and superior support are our priorities. XYZTEC is market leader in Europe and is steadily growing in other major territories globally. Customers are happy with our personal no-nonsense approach and recognize our unique selling points. Our production process is ISO 9001, ISO 13485 and ISO 14001 certified. Aiming to improve understanding of bond testing in the industry, XYZTEC organizes seminars. Contact us to learn more!
YASUI CO., LTD.

Japan

Yasui Co., Ltd. was founded in 1930 in Osaka as a printing company. We later broadened into areas including injection molding (mainly medical device parts) and medical products (original and OEM). We are ISO 9001 and ISO 13485 certified, reinforcing quality control and management to meet high international standards. We applied 90+ years of innovation and quality control in Japanese manufacturing to develop koplight, an original design that meets specific clinical needs. Yasui Medical is aggressively expanding its global reach, bringing Made in Japan quality to the world’s markets.

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MEDICA SUD GROUP

Tunisia

Manufacture and distribution of single-use ISO 13485- and CE-certified medical devices and textiles. We have been serving healthcare professionals and patients with our expertise for over 20 years. We guarantee stable supplies and consistent quality to our healthcare sector customers with the possibility of offering customized and bespoke products. We manufacture a full range of medical devices, operating drapes and protective coverings that cater for various medical specialities: surgical gowns, surgical drapes and kits, medical gowns, protective coveralls, operating theatre outfits, drainage sets, IV kits, etc. Furthermore, Ansell, the world's leading medical glove manufacturer, has awarded the exclusive licence to manufacture sterile powder-free Medi-GRIP gloves to Medica Sud Group, the producer and manufacturer of medical devices. Our products are exported throughout Europe, Africa and the Middle-East.
BIOCHEM BERNBURG GMBH

Germany

BIOCHEM Bernburg GmbH was established in 1991 as a trading and manufacturing company. Our main areas of expertise are now the manufacture of dialysis products, nutritional supplements and industrial cleaners as well as the procurement and supply of raw materials for the manufacture of pharmaceuticals, foodstuffs, cosmetics and chemicals. We have been manufacturing dialysis concentrates since 1998. Our company is IFS (Global Food Standard) and EN ISO 13485 certified. We also work in other production areas as a contract manufacturer for food, feed, fishkeeping and chemical products. We mix, fill and assemble solid and liquid products, also in compliance with BIO/Öko certification (DE-ÖKO-034). Since 2020, we have also been manufacturing hand and surface disinfectants and selling a range of medical products including medical disposable masks and coronavirus antigen tests.

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United States

Belgium

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PROSIM MEDICAL

Turkey

Prosim Medical, through its CYTRONICS brand, is an industry pioneer with a prolific production capacity. Via World standards prodution validity proven by customer satisfaction and manufacturing top quality orthopedic products and instruments, the company has become a worldwide brand. Prosim means a service based on a system with a high Standard of quality. We are constantly innovating and have aimed to continually improve our organization to be the best in the sector with our R&D and technological investments with our research universities and specialist surgeons. Prosim is an ISO 13485 certified company and all of the products are produced under CE Mark. Quality is always our first priority. The quality control department is equiped with CMM, profile projectors, Hardness measuring device among others. With our experienced staff, a high Standard of quality and best machine parkour in the country, we continue to lead the trauma orthopaedic implants market for more than two decades. Our machining departments includes swiss turning machines, CNC turning machines and milling machines where we manufacture locking and non-locking screws, instruments, straight and anatomic bone plates and similar products. Our bone plates re either wire cut with our cutting edge wire cutting machines or forged in our forging factory. At Prosim, we are driven to provide our custormers the best services at the right time at the lowest cost.
TGDENT

United Kingdom

We make the high quality tg brand range of Dental Materials. Our portfolio covers a wide range of applications: - Endodontics; Composites; Amalgams; Filling Materials; Cements & Liners, Disposable Dental Needles, Preventives, Temporary, Cross Infection Control, Impression Materials & other miscellaneous dental healthcare products. Our worldwide distribution network of subsidiaries and sales partners along with our wide range of products, guarantee an efficient and professional service for all our clients. The quality of our products and customer service is of the utmost importance to us. As a result, we continually strive to meet the highest possible standards. The high standards that we set for ourselves and our products, are not only limited to our organisation but extend to meet other requirements that our clients may have. The excellent quality of our wide range of products and competitive pricing is our primary focus, which when combined with our efficient dispatch policy assures you the best possible service. Our manufacturing facilities have the latest technology, production methods and the best in research and design. Certified BS EN 9001: 2015 Certified ISO 13485: 2016; Production of Medical Devices for use in Dentistry. Certified in accordance with Annex II of EU Council Directive 93/42/EEC. Certified from United Kingdom Department of Health for Class I materials. Free Sales certification from the UK Department of Health for export of Medical Products.
NORDISK FINMEKANIK INDUSTRI A/S

Denmark

Streamlined production of complex, precision components. System supplier with assembly facilities and a large network of subcontractors ISO 9001 certified. Prototype production. Construction and development. Design optimization for improved performance/cost ratio. All processes are systematically planned, which - combined with state-of-the-art production equipment and the specialist staff - guarantees a high-quality serial production of items with a high level of complexity. Separate production facilities for "medical device" components, for manufacturing items with specific requirements and documented purity value. Delivery of components that are processed and packaged in a clean room environment to be used directly in hospital and laboratory equipment, surgical instruments and implants for dental and orthopedic surgery. Separate production equipment with ultra-high precision. 24m² cleanroom ISO class 5. ISO 13485 certified production. Production in Denmark and Czech Republic.
ORIGINAL MEDICAL EQUIPMENT CO PVT LTD

India

Original Medical Equipment Co Pvt Ltd is an ISO 13485 certified company and are manufacturing and supplying superior quality Stainless Steel, Plastic and Aluminum hospital hollowares and furniture. The complete range of Hospital Hollowares includes Kidney trays, Surgical Trays, Galipots, Urinals, Bed Pans and numerous other products and a comprehensive range of Hospital Furniture includes Hospital Beds, Examination/operation Tables, Trolleys and carts, Stretchers, Delivery tables and Examination couches, Cabinets and Cupboards etc. We also supply the superior quality Disposable sharp containers etc. The company is registered with FDA (Food and Drug Administration, USA) and most of its products are CE marked.Please send us your valuable enquiries to us for best offer.Thanking you and with best regards, A Raj Singh
TAGUS PHARMA

Portugal

Tagus Pharma focuses on Ostomy & incontinence care solutions, known as European manufacturer of ostomy supplies, carrying the lCE, ISO 13485 & 9001 certified product portfolio, for almost every ostomy needs: 1) Ostomy Appliances: One/Two-piece systems; Colostomy, Ileostomy, Urostomy Bags / Pouches. 2) Ostomy Accessories: Ostomy Belts, Clamps, Skin Barriers, Paste, Deodorant, etc. 3) Incontinence Supplies: Urine Bags, . Today, we are in the process of developing relationships with like-minded companies around the world to distribute our products in other markets. Join our expanding network. Giving you one more choice-an alternative option- serving your clients better! Favorable quotations to be sent upon specific inquires as well as free samples. OEM orders accepted! Medical devices .
IMPRO EUROPE

Luxembourg

Impro is a leading global manufacturer of high-precision, high-complexity and mission-critical casting and machined components for diverse end-markets. We supply precision castings and machined components to a global customer base. Impro manufacturing plants are located in China, Turkey, Germany, and Mexico. They are IATF 16949, ISO 9001, ISO 9100, ISO 13485, and ISO 14001 certified. Our integrated business model enables us to provide one-stop solutions to our customers for their precision component needs. We produce investment castings ranging from a few oz. to 200 lbs. Iron sand casting process includes both green sand and resin sand casting, producing iron castings from a few kilograms up to 20 tons. Our machining capabilities include CNC turning, milling, 4- and 5- axis machining, grinding (centerless, cylindrical, ID, and OD), honing, deburring, and hard turning. Materials worked with include stainless steel, low alloy steel, carbon steel, titanium, super alloys, aluminum, copper, structural steel, spring steel, tool steel, ductile iron, gray iron, and more. Rapid prototyping services are available. Other value-added services include on-site engineering, in-house tooling design and manufacture, research and development, lab testing, heat treatment, and surface treatment. We have central warehouse location in Luxembourg, multiple plants and sales offices in Europe to provide local logistics, technical and quality services.
UNIK SURGICAL SUTURES MFG. CO.,

Taiwan R.O.C.

Unik is a GMP factory which has been approved to the quality system by the Ministry of Health of Taiwan; also Unik has ISO 13485 certifying to conform to the Quality Management System Standard. Recently we received CE Mark for Non-Absorbable and Absorbable Surgical Sutures. SPECIFICATION: Chromic Catgut Sutures / Plain Catgut Sutures / Monofilament Nylon Sutures Silk Sutures / Polyester Sutures / Polypropylene Sutures / Braided Nylon Sutures PGA Synthetic Absorbable Sutures (Violet) / Wire Sutures
MEDIMEAS INSTRUMENTS

India

MEDIMEAS, for the last 35 years, is creating innovative and smart histology lab equipment and optical measurement instruments that have become foundation of the industry.We manufacture quality products that excel in performance, features, reliability, conformance, durability, serviceability and aesthetics.With over 35 years experience in the histology lab equipment manufacturing business, we are committed to producing only the finest products to our customers. Our products are manufactured and sold direct from our factory in Ambala Cantt, Haryana, India. This enables us to keep pricing competitive. Our microtomes, tissue processors, tissue embedding systems, slide stainers are sold to and used in numerous pathology labs, hospitals and medical schools. Our manufacturing processes are ISO 9001, ISO 13485 certified and all our equipment are CE approved.

TELE-PAPERS (M) SDN BHD

Malaysia

TELE-PAPER, Malaysia , founded in 1989, is currently the largest ISO 9001 and ISO 13485 Certified direct thermal and thermal transfer products manufacturer in South East Asia. Backed by 24 years of experience in the thermal paper industry, TELE-PAPER, has grown into a full fledge thermal products manufacturer, operating from 2 factory sites, spanning across 40, 000 square meters, with over 20 printing presses and over 40 high tech slitting machines.Our medical chart papers are FDA registered and CE approved. A trusted company by over 93 countries around the globe, we produce the finest performance quality Medical Recording Chart Paper, Video Printer Paper and Ultrasound Gel.
ZHE JIANG KIRIN MEDICAL INSTRUMENTS TRADY CO.,LTD

China

We sell disposable medical supplies, interventional catheterization, repair dental materials, medical supplies, etc. particularly Precision thermoplastic tubing , catheters , and component assembly are used in the medical industry , are widely used in medical applications , especially in minimally invasive cardiology , neurology , urology and nephrology procedures . And we sell repair dental materials as Dentex All Purpose Light Cure Composite, Dentex Flowable Light Cure Composite and Dentex Self-etching Adhesive. we are ISO 13485: 2003-certified manufacturer and The products all have CE certification. If something you need , give me E-mail and discuss in detail.
MIV THERAPEUTICS (INDIA) PVT. LTD.

India

MIV Therapeutics (INDIA) Pvt. Ltd. is take this opportunity to introduce ourselves. We are fast growing Coronary Stent & plastic disposable medical device manufacturing company based in SURAT (INDIA).Our products SS Stents, Cobalt Chromium Stent, Inflation Device, Y-Connectors Push Pull Connector, Insertion Tool, and torquer are being exported to various destinations regularly. All the products being manufactured marketed locally and exported to different countries. Our products are internationally approved standards and pass through stringent quality control checks at every stage of manufacture from beginning till they reach the market place. We are an ISO 9001- 13485 & GMP certified company. Our all Products are CE approved.
WUHAN SITAILI MEDICAL CO.,LTD

China

SitailiMed focuses on only stoma & incontinence care solutions, known as China's leading manufacturer of ostomy supplies, carrying the largest CE, ISO 13485 & 9001 certified product portfolio, for almost every ostomy needs: 1) Ostomy Appliances: One/Two-piece systems; Colostomy, Ileostomy, Urostomy Bags / Pouches. 2) Ostomy Accessories: Ostomy Belts, Clamps, Skin Barriers, Paste, Deodorant, etc. 3) Incontinence Supplies: Urine Bags, Adult Diaper, Incontinence Pants / Underwear, etc. Today, we are in the process of developing relationships with like-minded companies around the world to distribute our products in other markets. Join our expanding network.SitailiMed giving you one more choice-an alternative option- serving your clients better! Favorable quotations to be sent upon specific inquires as well as free samples. OEM orders accepted!
SMILE SURGICAL IRELAND LIMITED

Ireland

Smile Surgical Ireland Limited is world’s best and leading manufacturer and supplier of premium quality Surgical & Dental Instruments to worldwide. We worked hard to build our reputation in this evolving industry and our satisfied customers are our strength. All of the Surgical & Dental Instruments supplied by us are ISO 9001: 2015, ISO 13485: 2012 and CE marked certified in accordance with the Medical Devices Directive. Our Mission At Smile Surgical Ireland Limited is: To provide our customers with outstanding customer support and provide quality Surgical & Dental instruments at the best and competitive prices. To provide our customers with a friendly, easy-to-use ordering system. To provide our customers with the latest products available. Our Policy At Smile Surgical Ireland Limited: To be the market leader in supplying the best and premium quality Surgical & Dental instruments at highly competitive and affordable prices. Fully understand the requirements of our respected customers and satisfy them. Strongly follow the policy “Customer First’’ and “Quality First’’ To continuously develop our technical experties on the basis of technology, customer’s feedback, and quality workforceTo form strategic joint ventures within the industry, and to fulfill our social, ethical and industrial obligations in the most effective and efficient manner.
DEAS SRL

Italy

Deas produces single-use medical breathing equipment for anaestheticians, intensive therapies and accident and emergency. Our range includes respiratory circuits for all types of ventilators, masks, filters, manual resuscitation equipment and tubes. Our products are guaranteed by meeting the requirements of standards in force and our EN ISO 13485 certified management system.
SBA SURGICAL

United States

We are manufacturers of all kinds of surgical, orthopedic, dental, orthodontics, gynecology, ophthalmic instruments and Minimally Invasive Spinal Surgery Instruments We are manufacturing all these instruments from German, French and American surgical grade Stainless Steel. We are also ISO-9001, ISO-13485, cGMP, and CE Certified.
LSA SURGICAL

Pakistan

LSA Surgical is a Manufacturer and Exporters of Quality Surgical Instruments and Dental Instruments. We are ISO 9001: 2008, ISO 13485 and CE certified company established since 1989. For more details please visit our website at : www.lsasurgical.com or you can ask for our detail catalog at our email mentioned.
FIRST PLANNER TRADING ENTERPRISE SDN BHD

Malaysia

FIRST PLANNER, Malaysia , founded in 1989, is currently the largest ISO 9001 and ISO 13485 Certified direct thermal and thermal transfer products manufacturer in South East Asia. Backed by 22 years of experience in the copy paper industry, FIRST PLANNER, has grown into a full fledge 100% Virgin Wood Pulp products manufacturer, operating from 2 factory sites, spanning across 40, 000 square meters, with over 20 printing presses and over 40 high tech slitting machines.
BHAT BIO-TECH INDIA (P) LTD.

India

Manufacturer of in vitro diagnostic test kits for Pregnancy, HIV, Hepatitis B, Hepatitis C, Malaria, Dengue, Chikungya Tests, etc.BBI is an ISO 9001, ISO 13485, GMP and CE Certified company.