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Usine Rotec Inc.

Manufacturer of medical devices registered in the European database in Baie-du-Febvre, Canada.

Registration number (SRN)CA-MF-000022549
Short nameRotec
RoleManufacturer
StatusActive
CountryCanada
CityJ0G1A0 Baie-du-Febvre
AddressRue de l'Église, 123 J0G1A0 Baie-du-Febvre
Registered on2022-04-08

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryUSINE ROTEC INC. (CA) · FDA 3001752600

Notified body certificates

CertificateStatusExpiryTypeBody
28620144083valid2027-07-05Quality management systemNB 2862

⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.

The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.

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