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BM Nasopharyngeal Airways
EUDAMEDClass I (EU MDR)
Ref 20380002Model 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 EUDAMED20380002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972091922384 EUDAMED
- Basic UDI-DI
- 697209192NPA12JE EUDAMED
- Direct Marketing DI
- 06972091922384 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
Category: Nasopharyngeal airway, single-use
BM Nasopharyngeal Airways by Bonree Medical Co., Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Nasopharyngeal airway, single-use.
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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 3a6b7dd2-8292-4b4e-960e-814365156ac5 61 fields · synced Aug 3, 2026