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Progenika Biopharma, S.A.

Manufacturer of medical devices registered in the European database in Derio, Spain.

Registration number (SRN)ES-MF-000001005
Short namePGK
RoleManufacturer
StatusActive
CountrySpain
City48160 Derio
AddressIbaizabal bidea, Edificio 504, 48160 Derio
Registered on2021-01-29

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryPROGENIKA BIOPHARMA S.A. (ES) · FDA 3006413195

Notified body certificates

CertificateStatusExpiryTypeBody
V13 076212 0030reissued2031-09-22Quality management systemNB 0123

⚠️ 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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