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Optos plc

Manufacturer of medical devices registered in the European database in Dunfermline, United Kingdom (excl. Northern Ireland).

Registration number (SRN)GB-MF-000019460
RoleManufacturer
StatusActive
CountryUnited Kingdom (excl. Northern Ireland)
CityKY11 8GR Dunfermline
AddressQueensferry House, Carnegie Campus, KY11 8GR Dunfermline
Registered on2022-01-25

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryOPTOS PLC (GB) · FDA 9617167

Notified body certificates

CertificateStatusExpiryTypeBody
HZ 1552432-1validexpired 2026-09-27Quality management systemNB 0197

⚠️ 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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