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Enbio Technology Sp. z o. o.

Manufacturer of medical devices registered in the European database in Gdynia, Poland.

Registration number (SRN)PL-MF-000024063
Short nameEnbio Technology
RoleManufacturer
StatusActive
CountryPoland
City81-029 Gdynia
AddressPółnocna, 10 81-029 Gdynia
Registered on2022-05-17

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryENBIO TECHNOLOGY SP. Z.O.O. (PL) · FDA 3018815412

Notified body certificates

CertificateStatusExpiryTypeBody
TNP/MDR/0047/4332/2026reissued2029-02-05Quality management systemNB 2274
TNP/MDR/0007/4332/2023validexpired 2026-02-05Quality management systemNB 2274

⚠️ 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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