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BM Oral Endotracheal Tubes
EUDAMEDClass IIa (EU MDR)
Ref 21095002Model Endotracheal Tubes (Cuffed): ID 2.5mm, 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 Oral Endotracheal Tubes EUDAMED
- Device Name
- Endotracheal Tubes EUDAMED
- Model / Reference
- Endotracheal Tubes (Cuffed): ID 2.5mm, 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 EUDAMED21095002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972091920472 EUDAMED
- Basic UDI-DI
- 697209192ETTC13N8 EUDAMED
- Direct Marketing DI
- 06972091920472 EUDAMED
- EMDN Code
- R01030201 ENDOTRACHEAL TUBES, CUFFED, NOT 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
BM Oral Endotracheal 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 | 697209192ETTC13N8 | 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 56a375e6-427a-4de5-82df-f19694af87d5 61 fields · synced Jul 19, 2026