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Os/60k
EUDAMEDClass IIa (EU MDR)
Ref OS/60KModel Oxygentherapy mask with variable concentration
by FIAB S.p.A.
Identity
- Model / Reference
- Oxygentherapy mask with variable concentration EUDAMEDOS/60K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033003260425 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
Os/60k 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 08436da3-2097-4eee-815b-f601fd09e02c 61 fields · synced Jun 20, 2026