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BM Urethral Dilators
EUDAMEDClass IIa (EU MDR)
Ref 404 24 22 2Model 8FR, 10FR, 12FR, 14FR, 16FR, 18FR, 20Fr, 22Fr, 24Fr, 26Fr
Identity
- Trade Name
- BM Urethral Dilators EUDAMED
- Device Name
- Urethral Dilators EUDAMED
- Model / Reference
- 8FR, 10FR, 12FR, 14FR, 16FR, 18FR, 20Fr, 22Fr, 24Fr, 26Fr EUDAMED404 24 22 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382609713 EUDAMED
- Basic UDI-DI
- 697209192UHD39L6 EUDAMED
- Direct Marketing DI
- 06942382609713 EUDAMED
- EMDN Code
- U03010201 URETHRAL DILATORS 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 Urethral Dilators 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 | 697209192UHD39L6 | 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 e3533626-411c-4128-8890-74d51eb94fd2 61 fields · synced Jun 11, 2026