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BM Tracheostomy Tube with Evacuation Lumen
EUDAMEDClass IIa (EU MDR)
Ref 225 50 00 2Model Tracheostomy Tube with Evacuation Lumen, ID: 5.0mm, 5.5mm, 6.0mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 9.5mm
Identity
- Trade Name
- BM Tracheostomy Tube with Evacuation Lumen EUDAMED
- Device Name
- Tracheostomy Tubes EUDAMED
- Model / Reference
- Tracheostomy Tube with Evacuation Lumen, ID: 5.0mm, 5.5mm, 6.0mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 9.5mm EUDAMED225 50 00 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972091927488 EUDAMED
- Basic UDI-DI
- 697209192TTE35NC EUDAMED
- Direct Marketing DI
- 06972091927488 EUDAMED
- EMDN Code
- R0105020101 TRACHEOSTOMIC CANNULAS, CUFFED, NOT REINFORCED, WITH FIXED FLANGE, AND KITS 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
Category: Tracheostomy tube, non-reinforced, non-customized, single-use
BM Tracheostomy Tube with Evacuation Lumen by Bonree Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 697209192TTE35NC | 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 a93c0555-10ce-4644-bafb-727511b07fa2 61 fields · synced Aug 1, 2026