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Medocare Oxygen Mask with Tubing
EUDAMEDClass IIa (EU MDR)
Ref 8906012462451Model Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant
Identity
- Trade Name
- Medocare Oxygen Mask with Tubing EUDAMED
- Device Name
- Oxygen Masks EUDAMED
- Model / Reference
- Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant EUDAMED8906012462451 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382602400 EUDAMED
- Basic UDI-DI
- 697209192OGM01JH EUDAMED
- Direct Marketing DI
- 06942382602400 EUDAMED
- EMDN Code
- R03010201 AIR/OXYGEN 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 Oxygen Mask with Tubing 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 | 697209192OGM01JH | 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 187c6bd7-bd2a-4e67-9043-bcf13a3d6938 61 fields · synced Jul 11, 2026