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Certificates

ISO 13485:2016 under MDSAP, Health Canada licences and CE Mark, ready to download.

Certified quality

Every MAJnMAR device is made under an audited quality system.

ISO

ISO 13485:2016 under MDSAP

Medical device quality management, audited by TÜV USA / TÜV NORD.

Cert. No. 24-1628-M

ISO 13485 MDSAP

HC

Health Canada MDEL

Medical Device Establishment Licence for import and distribution.

MDEL No. 6358

Medical Device Licences

CE

CE Mark

Conformity with European requirements for sale in the EU.

European Union

CE Certificate

Downloads

Certificates and licences

Download copies for your tender, registration or procurement file. For other documents, contact us at sales@majnmar.com.

Quality system

ISO 13485:2016 Certificate

Medical device quality management system certificate.

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Quality system

MDSAP Certificate

Medical Device Single Audit Program, Cert. No. 24-1628-M.

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Health Canada · Medical Device Licence

Endoscopic Linear Cutting Stapler

Health Canada Medical Device Licence (MDL).

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Health Canada · Medical Device Licence

Reloads for Endoscopic Linear Cutting Stapler

Health Canada Medical Device Licence (MDL).

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Health Canada · Medical Device Licence

Hernia Stapler

Health Canada Medical Device Licence (MDL).

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Health Canada · Medical Device Licence

Silicone Drains

Health Canada Medical Device Licence (MDL).

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European Union

CE Mark Certificate

Conformity with European medical device requirements.

Download PDF