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NIOX AB

Manufacturer of medical devices registered in the European database in Uppsala, Sweden.

Registration number (SRN)SE-MF-000010044
Short nameNIOX
RoleManufacturer
StatusActive
CountrySweden
City75450 Uppsala
AddressHansellisgatan, 13 75450 Uppsala
Registered on2021-07-16

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryNIOX AB (SE) · FDA 3008662397

Notified body certificates

CertificateStatusExpiryTypeBody
IX 1379539-1valid2031-06-11Technical documentationNB 0197
HX 1379539-1valid2031-06-11Quality 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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