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Medocare Venturi Mask
EUDAMEDClass IIa (EU MDR)
Ref 11001001Model Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant
Identity
- Trade Name
- Medocare Venturi Mask EUDAMED
- Device Name
- Multi-vent Masks EUDAMED
- Model / Reference
- Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant EUDAMED11001001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382604398 EUDAMED
- Basic UDI-DI
- 697209192MVM03M8 EUDAMED
- Direct Marketing DI
- 06942382604398 EUDAMED
- EMDN Code
- R03010202 VENTURI MASKS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
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
Medocare Venturi Mask by Bonree Medical Co., Ltd. — 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 | 697209192MVM03M8 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Bonree Medical Co., Ltd.
- EUDAMED SRN
- CN-MF-000017844
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d6fb4f9b-3d15-4f5e-a694-67d4979c6a40 61 fields · synced Jun 17, 2026