Niox AB
Active in EUDAMEDSwedenfrom SRN EUDAMED FDA SRN SE-MF-000010044 FEI 3008662397
- Devices
- 8
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
2 of 2 in force.
Market reach
- European Union
- EUDAMED actor, 2 certificates
- United States
- FDA FEI
Catalogue
Niox Vero Ref 12-1100
Regimes: CE IVDD Registry: EUDAMEDNiox Ref 12-1015
Regimes: CE MDR Registry: EUDAMEDNiox Pro Ref 20-1000
Regimes: CE IVDR Registry: EUDAMEDNiox Ref NIOX Nasal Kit
Regimes: CE MDR Registry: EUDAMEDNiox Ref NIOX Nasal Kits
Regimes: CE MDR Registry: EUDAMEDNiox Ref NIOX Filters
Regimes: CE MDR Registry: EUDAMEDNiox Ref 12-1020
Regimes: CE MDR Registry: EUDAMEDNiox Ref 20-1020
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- SE-MF-000010044
- FDA FEI number
- 3008662397
- EU VAT number
- SE 556 549 105 601
- EUDAMED status
- Active
- EUDAMED registered name
- NIOX AB
- EUDAMED abbreviated name
- NIOX
- Registered address
- 13, Hansellisgatan, 75450, Uppsala, Sweden
- [email protected]
- PRRC contact
- Katharine Tipper
EUDAMED certificates
2 certificates2 valid, 0 expiredIVDR 2next expiry 11 Jun 2031
TÜV Rheinland LGA Products GmbH 0197 2 certificates
- HX 1379539-1 Active
Quality management system EU IVDR
- Issued
- 12 Jun 2026
- Expires
- 11 Jun 2031
- IX 1379539-1 Active
Technical documentation EU IVDR
- Issued
- 6 Jul 2026
- Expires
- 11 Jun 2031
Frequently asked questions
How many devices does NIOX AB have in the registry?
The registry currently lists 8 devices for NIOX AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list NIOX AB's devices?
Among its 8 most recently registered devices, NIOX AB has devices listed in EUDAMED (8 devices).
What risk classes do NIOX AB's devices fall under?
Among its 8 most recently registered devices, the classes recorded for NIOX AB's devices are Class I, IVDR Class B and IVD general. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for NIOX AB?
EUDAMED lists 2 certificates for NIOX AB (quality management system; technical documentation) under IVDR. 2 are recorded with the status issued. The most recent was issued on 2026-07-06.
What are the newest devices from NIOX AB in the registry?
The most recently registered devices listed for NIOX AB include NIOX VERO, NIOX and NIOX PRO.