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BM High Flow Nasal Cannula
EUDAMEDClass IIa (EU MDR)
Ref 128 02 00 1Model Adult, Pediatric, Infant
Identity
- Trade Name
- BM High Flow Nasal Cannula EUDAMED
- Device Name
- High Flow Nasal Cannula EUDAMED
- Model / Reference
- Adult, Pediatric, Infant EUDAMED128 02 00 1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382610788 EUDAMED
- Basic UDI-DI
- 697209192HFNC45HQ EUDAMED
- Direct Marketing DI
- 06942382610788 EUDAMED
- EMDN Code
- R0301020302 HIGH FLOW THERAPY NASAL CANNULAS (HFNC) EUDAMED
Classification
- Device Class
- Class IIa 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 High Flow Nasal Cannula 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 | 697209192HFNC45HQ | 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 54a73213-1137-4d41-8885-5e7ecb16cbd4 61 fields · synced Sep 17, 2026