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BM Tracheostomy Tubes
EUDAMEDClass IIa (EU MDR)
Ref 22395002Model Uncuffed, ID: 3.0mm，ID: 3.5mm，ID: 4.0mm，ID: 4.5mm，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 Tracheostomy Tubes EUDAMED
- Device Name
- Tracheostomy Tubes EUDAMED
- Model / Reference
- Uncuffed, ID: 3.0mm，ID: 3.5mm，ID: 4.0mm，ID: 4.5mm，ID: 5.0mm, 5.5mm, 6.0mm, 6.5mm, 7.0mm, 7.5mm, 8.0mm, 8.5mm,9.0mm, 9.5mm, 10.0mm EUDAMED22395002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972091921462 EUDAMED
- Basic UDI-DI
- 697209192TTTU35XF EUDAMED
- Direct Marketing DI
- 06972091921462 EUDAMED
- EMDN Code
- R0105010101 TRACHEOSTOMIC CANNULAS, CUFFLESS, 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 Tubes by Bonree Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Tracheostomy tube, non-reinforced, non-customized, 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 | 697209192TTTU35XF | 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 c655f31b-4de2-469c-9692-316945b26dd9 61 fields · synced Aug 2, 2026