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Mask For Niv - Single Patient And Accessories
EUDAMEDClass IIa (EU MDR)
Ref SMASK-ACC020
Identity
- Device Name
- MASK FOR NIV - SINGLE PATIENT AND ACCESSORIES EUDAMED
- Model / Reference
- SMASK-ACC020 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058323089150 EUDAMED
- Basic UDI-DI
- 80583230DCSMASKLN EUDAMED
- Direct Marketing DI
- 08058323089150 EUDAMED
- EMDN Code
- R03010180 ARTIFICIAL VENTILATION MASKS - ACCESSORIES 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 04387083-91cd-4798-a747-fc5ecf851e64 61 fields · synced Aug 1, 2026