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BM Ureteral Dilation Balloon Catheters
EUDAMEDClass IIa (EU MDR)
Ref 406 07 22 2Model 4x40 4x60 4x100 5x40 5x60 5x100 6x40 6x60 6x100 7x40 7x60 7x100 8x40 8x60 8x100 10x40 10x60 10x100
Identity
- Trade Name
- BM Ureteral Dilation Balloon Catheters EUDAMED
- Device Name
- Ureteral Dilation Balloon Catheters EUDAMED
- Model / Reference
- 4x40 4x60 4x100 5x40 5x60 5x100 6x40 6x60 6x100 7x40 7x60 7x100 8x40 8x60 8x100 10x40 10x60 10x100 EUDAMED406 07 22 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972091927105 EUDAMED
- Basic UDI-DI
- 697209192UDBC40KD EUDAMED
- Direct Marketing DI
- 06972091927105 EUDAMED
- EMDN Code
- U030202 URETERAL DILATORS, WITH BALLOON 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 Dilation Balloon 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 | 697209192UDBC40KD | 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 8819fc0a-833c-47cd-82b9-3dbff7d6acc5 61 fields · synced Jul 31, 2026