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BM Reinforced Tracheostomy Tubes
EUDAMEDClass IIa (EU MDR)
Ref 227 80 00 2Model Reinforced uncuffed,ID: 5.0mm, 5.5mm, 6.0mm,6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 9.5mm, 10.0mm
Identity
- Trade Name
- BM Reinforced Tracheostomy Tubes EUDAMED
- Device Name
- Tracheostomy Tubes EUDAMED
- Model / Reference
- Reinforced uncuffed,ID: 5.0mm, 5.5mm, 6.0mm,6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm, 9.0mm, 9.5mm, 10.0mm EUDAMED227 80 00 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972091927853 EUDAMED
- Basic UDI-DI
- 697209192RTTU35WM EUDAMED
- Direct Marketing DI
- 06972091927853 EUDAMED
- EMDN Code
- R0105010201 TRACHEOSTOMIC CANNULAS, CUFFLESS, 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
BM Reinforced Tracheostomy Tubes 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 | 697209192RTTU35WM | 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 0415c268-3ff1-4302-8232-b357592fba6d 61 fields · synced Aug 1, 2026