Hidroxa Medical AB
Active in EUDAMEDSwedenfrom SRN EUDAMED SRN SE-MF-000048119
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What Hidroxa Medical AB makes
Hidroxa Medical AB manufactures the Hidroxa SE30, a medical device designed for sterile irrigation and wound care applications, ensuring controlled fluid delivery in clinical settings.
The Hidroxa SE30 is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Hidroxa SE30 Ref SE30-011
Regimes: CE MDR Registry: EUDAMEDHidroxa SE30 Ref K241267
Regimes: CE MDR 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- SE-MF-000048119
- EU VAT number
- SE556965824701
- EUDAMED status
- Active
- EUDAMED registered name
- Hidroxa Medical AB
- Registered address
- 114, Björndammsterrassen, 43342, Partille, Sweden
- Website
- www.hidroxa.com
- [email protected]
- PRRC contact
- Jimmy Eriksson
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 4 Jun 2031
SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ 1304 1 certificate
- MDR-0042 Active
Quality management system EU MDR
- Issued
- 5 Jun 2026
- Expires
- 4 Jun 2031
Frequently asked questions
How many devices does Hidroxa Medical AB have in the registry?
The registry currently lists 2 devices for Hidroxa Medical AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hidroxa Medical AB's devices?
Among its 2 most recently registered devices, Hidroxa Medical AB has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Hidroxa Medical AB's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hidroxa Medical AB's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Hidroxa Medical AB?
EUDAMED lists 1 certificate for Hidroxa Medical AB (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 5 Jun 2026.
What are the newest devices from Hidroxa Medical AB in the registry?
The most recently registered devices listed for Hidroxa Medical AB include Hidroxa SE30.