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Mask For Niv - Single Patient And Accessories
EUDAMEDClass IIa (EU MDR)
Ref SMASK-016L
Identity
- Device Name
- MASK FOR NIV - SINGLE PATIENT AND ACCESSORIES EUDAMED
- Model / Reference
- SMASK-016L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058323057227 EUDAMED
- Basic UDI-DI
- 80583230DCSMASKLN EUDAMED
- Direct Marketing DI
- 08058323057227 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
Mask For Niv - Single Patient And Accessories by Intersurgical SpA — 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 | 80583230DCSMASKLN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Intersurgical SpA
- EUDAMED SRN
- IT-MF-000010729
Sources (1)
- EUDAMED bbbe3d82-47ac-403f-bf90-4f8cd986ea52 61 fields · synced Jul 29, 2026