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BM Nasopharyngeal Airways
EUDAMEDClass I (EU MDR)
Ref 20385002Model ID 3.0mm,3.5mm,4.0mm,4.5mm,5.0mm,5.5mm,6.0mm,6.5mm,7.0mm,7.5mm,8.0mm,8.5mm,9.0mm
Identity
- Trade Name
- BM Nasopharyngeal Airways EUDAMED
- Device Name
- Nasopharyngeal Airways EUDAMED
- Model / Reference
- ID 3.0mm,3.5mm,4.0mm,4.5mm,5.0mm,5.5mm,6.0mm,6.5mm,7.0mm,7.5mm,8.0mm,8.5mm,9.0mm EUDAMED20385002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972091922391 EUDAMED
- Basic UDI-DI
- 697209192NPA12JE EUDAMED
- Direct Marketing DI
- 06972091922391 EUDAMED
- EMDN Code
- R010101 NASOPHARYNGEAL 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 Nasopharyngeal 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 | 697209192NPA12JE | 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 55e72d3d-f9c3-4246-a508-a006dc45d2f3 61 fields · synced Jun 19, 2026