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BM Oropharyngeal Airways
EUDAMEDClass I (EU MDR)
Ref 20111002Model Guedel Type: 40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 100mm, 110mm, 120mm
Identity
- Trade Name
- BM Oropharyngeal Airways EUDAMED
- Device Name
- Oropharyngeal Airways EUDAMED
- Model / Reference
- Guedel Type: 40mm, 50mm, 60mm, 70mm, 80mm, 90mm, 100mm, 110mm, 120mm EUDAMED20111002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972091922186 EUDAMED
- Basic UDI-DI
- 697209192OPA11JP EUDAMED
- Direct Marketing DI
- 06972091922186 EUDAMED
- EMDN Code
- R010102 GUEDEL AIRWAY TUBES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
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
BM Oropharyngeal Airways by Bonree Medical Co., Ltd. — 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 | 697209192OPA11JP | Class I | 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 2cef1118-8662-4329-bc2b-c76f7116a4a0 61 fields · synced Oct 6, 2026