Medical Certifications

submed medical certifications

SUBMED Components and Kits are FDA Certified for Medical Use

Submed, a surgical pack company, is eligible to ship to the U.S., having met all FDA requirements, including establishment registration, device listing, and Quality System Regulation compliance for labeling, packaging, and sterilization. With an FDA export certificate (e.g., Certificate to a Foreign Government or Certificate of Free Sale) obtained via the CDRH system and accurate entry data submitted through the Automated Commercial Environment, Submed ensures its surgical packs meet U.S. standards for lawful importation and distribution.

General Certificates

EN ISO 13485 Medical Devices — Quality management systems — Requirements for regulatory purposes

As Sample Store uses some of the latest graphics designs which may not be supported in lower version of browsers
EN ISO 9001 Quality management systems — Requirements

As Sample Store uses some of the latest graphics designs which may not be supported in lower version of browsers
EN ISO 11135 Sterilization of health-care products — Ethylene oxide

As Sample Store uses some of the latest graphics designs which may not be supported in lower version of browsers
EN ISO 14971 Medical devices — Application of risk management to medical devices

As Sample Store uses some of the latest graphics designs which may not be supported in lower version of browsers

Test Certificates

EN ISO 13485 Medical Devices — Quality management systems — Requirements for regulatory purposes

As Sample Store uses some of the latest graphics designs which may not be supported in lower version of browsers
EN ISO 9001 Quality management systems — Requirements

As Sample Store uses some of the latest graphics designs which may not be supported in lower version of browsers
EN ISO 11135 Sterilization of health-care products — Ethylene oxide

As Sample Store uses some of the latest graphics designs which may not be supported in lower version of browsers
EN ISO 14971 Medical devices — Application of risk management to medical devices

As Sample Store uses some of the latest graphics designs which may not be supported in lower version of browsers

Clean Room Certificates

EN ISO 13485 Medical Devices — Quality management systems — Requirements for regulatory purposes

As Sample Store uses some of the latest graphics designs which may not be supported in lower version of browsers
EN ISO 9001 Quality management systems — Requirements

As Sample Store uses some of the latest graphics designs which may not be supported in lower version of browsers
EN ISO 11135 Sterilization of health-care products — Ethylene oxide

As Sample Store uses some of the latest graphics designs which may not be supported in lower version of browsers
EN ISO 14971 Medical devices — Application of risk management to medical devices

As Sample Store uses some of the latest graphics designs which may not be supported in lower version of browsers

About Us

SUBMED is a trusted MedTech provider specializing in custom sterile surgical packs that support infection control, surgical precision, and clinical efficiency.

Learn More About SUBMED

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