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Certificates

Certificate copies are provided to distributors for product registration with NAFDAC, COFEPRIS, SFDA, FDA-PH and other authorities. Ask the export team for the current versions and the full registration document pack.

CE — Directive 93/42/EEC, Dental UnitsIssued by SGS Fimko (Notified Body 0598) · PDF

ISO 13485:2016 — Quality managementIssued by NQA (UKAS) · Certificate No. 47083 · PDF

Registration document pack

Registration documentsTechnical file, instructions for use and authorisation letter — supplied to appointed distributors

Distributors receive the full registration document pack: certificates, technical file, instructions for use and a notarised authorisation letter.