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BM Reinforced Endotracheal Tubes
EUDAMEDClass IIa (EU MDR)
Ref 21550002Model Uncuffed: ID 3.0mm, ID 3.5mm, ID 4.0mm, ID 4.5mm, ID 5.0mm, ID 5.5mm, ID 6.0mm, ID 6.5mm, ID 7.0mm, ID 7.5mm, ID 8.0mm, ID 8.5mm, ID 9.0mm, ID 9.5mm, ID 10.0mm
Identity
- Trade Name
- BM Reinforced Endotracheal Tubes EUDAMED
- Device Name
- Reinforced Endotracheal Tubes EUDAMED
- Model / Reference
- Uncuffed: ID 3.0mm, ID 3.5mm, ID 4.0mm, ID 4.5mm, ID 5.0mm, ID 5.5mm, ID 6.0mm, ID 6.5mm, ID 7.0mm, ID 7.5mm, ID 8.0mm, ID 8.5mm, ID 9.0mm, ID 9.5mm, ID 10.0mm EUDAMED21550002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972091921080 EUDAMED
- Basic UDI-DI
- 697209192RETU14R8 EUDAMED
- Direct Marketing DI
- 06972091921080 EUDAMED
- EMDN Code
- R01030102 ENDOTRACHEAL TUBES, CUFFLESS, REINFORCED 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: Reinforced endotracheal tube, single-use
BM Reinforced Endotracheal Tubes by Bonree Medical Co., Ltd. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Reinforced endotracheal tube, single-use.
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- Endotracheal Tube — HANGZHOU FORMED MEDICAL DEVICES CO., LTD. · Class IIa
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 | 697209192RETU14R8 | 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 6ca633c5-c1fe-43e2-8191-30bd6e2c83b5 61 fields · synced Sep 17, 2026