Medical device - Import export

Part Number: BGB320240-02 ● Graphic LCD 320 x 240 (dots) ● FSTN-Gray / STN-Gray / STN-YG / STN-Blue ● Built-in controller ((RA8835 or Equivalent) ● +3.3V / +5.0V power supply ● 1/240 duty, 1/17bias ● Viewing Direction: 6H / 12H ● Interface: 6800/8080 8-bit parallel ● Backlight (Side LED): White / Green / Blue / Yellow-Green / RGB / Orange / Amber ● Temp: N.T / W.T / Super W.T

Part No. ：BCB2004-03 ● Character LCD 20x4 (5 x 8 dots) ● FSTN-Gray / STN-Gray / STN-YG / STN-Blue ● Bulit-in controller (ST7066U or Equivalent) ● +3.3V / +5.0V power supply ● 1/16 Duty , 1/5 Bias ● Viewing Direction: 6H / 12H ● Interface: 6800 4/8-bit parallel, optional SPI / I2C (RW1063 IC) ● Backlight (Side LED): White / Green / Blue / Yellow-Green / RGB / Orange / Amber ● Temp: N.T / W.T / Super W.T ● Fonts: English-Japanese / English-European / English-Cyrillic (Russian)

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Dymax MD® 1040M is a versatile autoclave resistant adhesive, coating and encapsulant resistant to numerous cycles of sterilization. Features: -STERRAD and autoclave resistant of 100+ cycles, including nonyellowing - Low water absorption 0.5% - UV/Broad Spectrum and LED curable at 365nm - Compliant with ISO 109935 Cytotoxicity - IBOA free (a known skin irritant) - Compliant with RoHS directives 2015/863/EU - Solvent free

For many applications such as machine tools, medical devices, vacuum and measuring equipment, as well as complex bearing systems, GMN develops and offers special ball bearings which meet our customers’ specified requirements.

Customized designs to capture lethal endotoxins The ALTECO ® LPS Adsorber is a unique medical device for extracorporeal removal of endotoxins during hemoperfusion that uses a synthetic peptide to selectively and irreversibly bind several times the endotoxin load found in patients with severe sepsis. In partnership with Alteco, Porex designed the porous matrix to provide an optimal binding surface for the peptide coating. Customizable for many blood filtration solutions, POREX ® porous media: Can be customized to your design specifications – Customized two- and three-dimensional porous matrix shapes can be developed for precise filtering and flow requirements. Can be functionalized – Proprietary binders and other media can be incorporated into the porous matrix to functionalize the filtering and binding capabilities. Delivers high-quality and consistent reliability– Medical device manufacturers around the world rely on our customized medical device components, which provide...

Customized designs to capture lethal endotoxins The ALTECO ® LPS Adsorber is a unique medical device for extracorporeal removal of endotoxins during hemoperfusion that uses a synthetic peptide to selectively and irreversibly bind several times the endotoxin load found in patients with severe sepsis. In partnership with Alteco, Porex designed the porous matrix to provide an optimal binding surface for the peptide coating. Customizable for many blood filtration solutions, POREX ® porous media: Can be customized to your design specifications – Customized two- and three-dimensional porous matrix shapes can be developed for precise filtering and flow requirements. Can be functionalized – Proprietary binders and other media can be incorporated into the porous matrix to functionalize the filtering and binding capabilities. Delivers high-quality and consistent reliability– Medical device manufacturers around the world rely on our customized medical device components, which provide...

Customized designs to capture lethal endotoxins The ALTECO ® LPS Adsorber is a unique medical device for extracorporeal removal of endotoxins during hemoperfusion that uses a synthetic peptide to selectively and irreversibly bind several times the endotoxin load found in patients with severe sepsis. In partnership with Alteco, Porex designed the porous matrix to provide an optimal binding surface for the peptide coating. Customizable for many blood filtration solutions, POREX ® porous media: Can be customized to your design specifications – Customized two- and three-dimensional porous matrix shapes can be developed for precise filtering and flow requirements. Can be functionalized – Proprietary binders and other media can be incorporated into the porous matrix to functionalize the filtering and binding capabilities. Delivers high-quality and consistent reliability– Medical device manufacturers around the world rely on our customized medical device components, which provide...

Customized designs to capture lethal endotoxins The ALTECO ® LPS Adsorber is a unique medical device for extracorporeal removal of endotoxins during hemoperfusion that uses a synthetic peptide to selectively and irreversibly bind several times the endotoxin load found in patients with severe sepsis. In partnership with Alteco, Porex designed the porous matrix to provide an optimal binding surface for the peptide coating. Customizable for many blood filtration solutions, POREX ® porous media: Can be customized to your design specifications – Customized two- and three-dimensional porous matrix shapes can be developed for precise filtering and flow requirements. Can be functionalized – Proprietary binders and other media can be incorporated into the porous matrix to functionalize the filtering and binding capabilities. Delivers high-quality and consistent reliability– Medical device manufacturers around the world rely on our customized medical device components, which provide...

MD® 250CTH epoxy is designed for rapid assembly of medical devices with flexible curing options using light only, heat only, or combination of the two. Features: - Cures with UV/Visible light - Secondary heat cure at 8085°C - Flexible light and heat cure - Semiopaque white color - Volumetric shrinkage at 1.3% - High modulus and durometer - No nonreactive solvents - Compliant with ISO 10993

Draw-wire sensors of the wireSENSOR series measure almost linearly over the entire measuring range and are used for distance and position measurements between 50 mm and 50,000 mm. Draw-wire sensors from Micro-Epsilon are ideal for both direct integration and subsequent assembly in serial OEM applications, e.g., in medical devices, lifts, conveyors and automotive engineering.

Stainless steel gas springs function the same as their common hydraulic counterparts, but give an alternative when operating under rough conditions such as off-shore and other outdoor exposure applications. Other commons application areas for stainless steel gas spring include health care products, food industry and medical devices.

Smart embroidery is one of the most well-known technologies to add functions to and integrate them in textiles. Thus, we produce intelligent textiles with our special CNC wire laying technology. Potential applications include: > textile-based electrodes > flexible antennas > textile sensors > medical devices reliant on electromagnetic coils

The testing machines of model series 215 were developed and built for applications with extremely small measuring ranges, below 0.1 Ncm, and highest precision. They are for example used in watch idustry or medical technology. All torsion testing machines are equipped with the TesTController 850 that is TEDS compatible. The corresponding software TesTWinner® provides the user - besides to its free programmability - an immense repertoire of possibilities for standard test procedures and routine test execution, evaluation, presentation and further processing of results, automation of processes and much more. A wide application field is guaranteed by a comprehensive range of accessory.

Class I of Regulation EU 2017/745 on medical devices; Type II R (liquidresistant), tested according to EN 14683 2019 for surgical masks. The inside and outside are made of physiologically harmless, plasticizerfree polypropylene fleece, the filter medium consists of a special microfiber fleece produced using the meltblown process, welded together using the ultrasound process.

Class I of Regulation EU 2017/745 on medical devices; Type II R (liquidresistant), tested according to EN 14683 2019 for surgical masks. The inside and outside are made of physiologically harmless, plasticizerfree polypropylene fleece, the filter medium consists of a special microfiber fleece produced using the meltblown process, welded together using the ultrasound process.

Class I of Regulation EU 2017/745 on medical devices; Type II R (liquidresistant), tested according to EN 14683 2019 for surgical masks. The inside and outside are made of physiologically harmless, plasticizerfree polypropylene fleece, the filter medium consists of a special microfiber fleece produced using the meltblown process, welded together using the ultrasound process.

Class I of Regulation EU 2017/745 on medical devices; Type II R (liquidresistant), tested according to EN 14683 2019 for surgical masks. The inside and outside are made of physiologically harmless, plasticizerfree polypropylene fleece, the filter medium consists of a special microfiber fleece produced using the meltblown process, welded together using the ultrasound process.

Class I of Regulation EU 2017/745 on medical devices; Type II R (liquidresistant), tested according to EN 14683 2019 for surgical masks. The inside and outside are made of physiologically harmless, plasticizerfree polypropylene fleece, the filter medium consists of a special microfiber fleece produced using the meltblown process, welded together using the ultrasound process.

Maxcert is offering EC Representative services for non EU medical devices manufacturers. Maxcert is authorized/ registered EC REP service provider and can manage your ECREP requirements better than others. We make sure that you are MDR ready! and well updated with the EU regulations for your medical devices. Maxcert’s team has expert knowledge to help you navigate through the complex regulatory challenges that the new EU MDR bring. We can assist you through out the entire process to ensure that you and your business are compliant with all of the EU MDR requirements. For more information, reach out to us at

Our experienced team has for years done documentation for companies who are manufacturers of medical devices /surgical instruments. We provide Quality-Management-Systems for meeting legal and normative requirements. For manufacturers of medical devices / surgical instruments class I (including Is, Im, and new for MDR class Ir), IIa, and IIb we offer the following services:
 Implementation DIN EN ISO 13485 and the EU-Regulation 2017/745 MDR and 21 CFR 820 QSR Creating QM-Systems with procedural instructions and work instructions Technical Documentation Clinical evaluation Risk Management / Risk Analysis Essential Safety and Performance Requirements Validation of processes UDI-labeling Consulting for Regulatory Affairs Internal audits and external supplier audits Accompaniment and support with inspections by authorities and Audits by notified bodies Communication with authorities