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BM Endotracheal Tube Introducers (bougie)
EUDAMEDClass IIa (EU MDR)
Ref 20410002Model Solid: 6Fr, 10Fr, 15Fr ;Hollow: 10Fr, 15Fr
Identity
- Trade Name
- BM Endotracheal Tube Introducers (bougie) EUDAMED
- Device Name
- Endotracheal Tube Introducers (bougie) EUDAMED
- Model / Reference
- Solid: 6Fr, 10Fr, 15Fr ;Hollow: 10Fr, 15Fr EUDAMED20410002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972091922070 EUDAMED
- Basic UDI-DI
- 697209192ETI17HR EUDAMED
- Direct Marketing DI
- 06972091922070 EUDAMED
- EMDN Code
- R018004 INTUBATION DEVICE GUIDES 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 Endotracheal Tube Introducers (bougie) 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 | 697209192ETI17HR | 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 cb28513b-ab8f-4a9c-bf61-0cddb381fded 61 fields · synced Sep 18, 2026