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Accessories For Niv Single-Patient Mask
EUDAMEDClass I (EU MDR)
Ref SMASK-ACC005S/M
Identity
- Device Name
- ACCESSORIES FOR NIV SINGLE-PATIENT MASK EUDAMED
- Model / Reference
- SMASK-ACC005S/M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058323041752 EUDAMED
- Basic UDI-DI
- 80583230DCSMASK-ACCBR EUDAMED
- Direct Marketing DI
- 08058323041752 EUDAMED
- EMDN Code
- R03010180 ARTIFICIAL VENTILATION MASKS - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
Accessories For Niv Single-Patient Mask by Intersurgical SpA — Class I — 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 | 80583230DCSMASK-ACCBR | Class I | Active |
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Manufacturer
- Manufacturer
- Intersurgical SpA
- EUDAMED SRN
- IT-MF-000010729
Sources (1)
- EUDAMED 3a0f0f34-b1ae-4beb-afb7-4dee6be824cd 61 fields · synced Jun 19, 2026