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Os6k
EUDAMEDClass IIa (EU MDR)
Ref OS6KModel Oxygentherapy mask with variable concentration
by FIAB S.p.A.
Identity
- Model / Reference
- Oxygentherapy mask with variable concentration EUDAMEDOS6K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033003268124 EUDAMED
- Basic UDI-DI
- 803300326101000005K9 EUDAMED
- EMDN Code
- R03010202 VENTURI MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Os6k by FIAB S.p.A. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803300326101000005K9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (1)
- EUDAMED 83b0ef88-26c2-439d-b8f2-0dd5c4c165e8 61 fields · synced Jun 20, 2026