Quality certificates and public evidence

Holder, address and reference fields are withheld at the partner's request; complete documents are shared through an authorised qualification process. Note on the FDA entry: the FDA does not issue registration certificates — that card is a redacted screenshot of public registration information, not a certificate.

EU MDR Quality Management SystemRegulation (EU) 2017/745 · Class IIb pen injector scope · valid to 2030-09-02 MDSAP · ISO 13485:2016Australia · Brazil · Canada · Japan · United States · expires 2029-02-11 EU MDR Device ScopeClass IIb · cartridge syringes · reusable and disposable pen injector. MDSAP Regulatory RequirementsAudit criteria for Australia, Brazil, Canada, Japan and the United States. FDA Establishment RegistrationFiscal Year 2024 registration information · not an FDA product approval.

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Identity withheld

FDA 510(k) records A manufacturing partner holds two US FDA 510(k) clearances for pen injector devices. Check the records →