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Medocare Non Rebreathing Mask with Tubing
EUDAMEDClass IIa (EU MDR)
Ref 8906012462447Model Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant
Identity
- Trade Name
- Medocare Non Rebreathing Mask with Tubing EUDAMED
- Device Name
- Non-Rebreathing Masks EUDAMED
- Model / Reference
- Adult Elongated, Adult Standard, Pediatric Elongated, Pediatric Standard, Infant EUDAMED8906012462447 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382602448 EUDAMED
- Basic UDI-DI
- 697209192NBM04H9 EUDAMED
- Direct Marketing DI
- 06942382602448 EUDAMED
- EMDN Code
- R03010206 MASKS WITH RESERVOIR 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 Non Rebreathing 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 | 697209192NBM04H9 | 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 8cd298cb-758e-40b2-8bb2-39c7a8600ea5 61 fields · synced Oct 6, 2026