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Sign in to claim this brandFOGLESS INTERNATIONAL AB
Sweden·SE-MF-000001616
Last updated September 17, 2026
Information
- Country
- Sweden
- Address
- 24, Storgatan, Vaggeryd, Sweden
- Website
- foglesshealth.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Jason Walton
- EUDAMED SRN
- SE-MF-000001616
- FDA FEI Number
- 3014054118
- DUNS Number
- —
Catalogue (5)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SPIRO Humidifier | 702 | EUDAMED | Class IIa | Active |
| Spiro Speaking Valve With Oxygen Port Spiro Speaking Valve Without Oxygen Port | K122932 | FDA 510(k) | Class II | Active |
| Spiro | 730-2K | EUDAMED | Class I | Active |
| Spiro | 703-2K | EUDAMED | Class I | Active |
| Spiro | 711-5K | EUDAMED | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Fogless International AB US