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Os/110k
EUDAMEDClass IIa (EU MDR)
Ref OS/110KModel Oxygen therapy mask for tracheostomy with variable concentration
by FIAB S.p.A.
Identity
- Model / Reference
- Oxygen therapy mask for tracheostomy with variable concentration EUDAMEDOS/110K EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033695727190 EUDAMED
- Basic UDI-DI
- 803300326101000008KF EUDAMED
- EMDN Code
- R030199 RESPIRATORY MASKS - OTHER 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
Category: Anaesthesia face mask, single-use
Os/110k by FIAB S.p.A. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 803300326101000008KF | Class IIa | Active |
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Manufacturer
- Manufacturer
- FIAB S.p.A.
- EUDAMED SRN
- IT-MF-000005988
Sources (1)
- EUDAMED c46a72e6-5df6-4eb1-b658-d9c2f7de1654 61 fields · synced Jun 19, 2026