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BM Ureteral Catheters
EUDAMEDClass IIa (EU MDR)
Ref 323 40 02 2Model 4.0FR, 5.0FR, 6.0FR, 7.0FR, 8.0FR
Identity
- Trade Name
- BM Ureteral Catheters EUDAMED
- Device Name
- Ureteral Catheters EUDAMED
- Model / Reference
- 4.0FR, 5.0FR, 6.0FR, 7.0FR, 8.0FR EUDAMED323 40 02 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382609942 EUDAMED
- Basic UDI-DI
- 697209192UTC32N7 EUDAMED
- Direct Marketing DI
- 06942382609942 EUDAMED
- EMDN Code
- U020101 URETERAL CATHETERS WITH CYLINDRICAL TIP 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 Ureteral Catheters 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 | 697209192UTC32N7 | 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 b5fe84b7-e7dd-495a-a5fc-ab6aeb832685 61 fields · synced Jul 30, 2026