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Mask For Niv Reusable And Accessories
EUDAMEDClass IIa (EU MDR)
Ref SMASKR-002M
Identity
- Device Name
- MASK FOR NIV REUSABLE AND ACCESSORIES EUDAMED
- Model / Reference
- SMASKR-002M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058323041660 EUDAMED
- Basic UDI-DI
- 80583230DCSMASKRVE EUDAMED
- Direct Marketing DI
- 08058323041660 EUDAMED
- EMDN Code
- R0301010202 NIV 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
Category: Rebreathing oxygen face mask
Mask For Niv Reusable And Accessories by Intersurgical SpA — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Rebreathing oxygen face mask.
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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 | 80583230DCSMASKRVE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Intersurgical SpA
- EUDAMED SRN
- IT-MF-000010729
Sources (1)
- EUDAMED ec349f85-4614-4d4e-bd17-a2ab3e570e3e 61 fields · synced Jul 12, 2026