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Surgical non-sterile face mask, type: IIR, packing: 10/1 (box)
EUDAMEDClass I (EU MDR)
Ref 960730Model Surgical non-sterile face mask
Identity
- Trade Name
- Surgical non-sterile face mask, type: IIR, packing: 10/1 (box) EUDAMED
- Device Name
- Surgical non-sterile face mask EUDAMED
- Model / Reference
- Surgical non-sterile face mask EUDAMED960730 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08600099007878 EUDAMED
- Basic UDI-DI
- 8600099HIRNESTMASKE4S EUDAMED
- Direct Marketing DI
- 08600099007878 EUDAMED
- EMDN Code
- T020604 MEDICAL USE FACE MASKS, TYPE II AND IIR EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Surgical non-sterile face mask, type: IIR, packing: 10/1 (box) by Niva Doo Žabalj — 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 | 8600099HIRNESTMASKE4S | Class I | Active |
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Manufacturer
- Manufacturer
- Niva Doo Žabalj
- EUDAMED SRN
- RS-MF-000025025
- Authorised Representative
- Salus Cons Kft. HU-AR-000006177
Sources (1)
- EUDAMED eb84fe2c-7f6e-40bd-a4ec-bf49208560e7 61 fields · synced Jun 19, 2026