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BM Zebra Nitinol Core Guidewire With Hydrophilic Tip
EUDAMEDClass IIa (EU MDR)
Ref 325 35 01 2Model Zebra Guidewire：0.018”, 0.025”, 0.028”, 0.032”, 0.035”, 0.038” "
Identity
- Trade Name
- BM Zebra Nitinol Core Guidewire With Hydrophilic Tip EUDAMED
- Device Name
- Guidewires EUDAMED
- Model / Reference
- Zebra Guidewire：0.018”, 0.025”, 0.028”, 0.032”, 0.035”, 0.038” " EUDAMED325 35 01 2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942382610962 EUDAMED
- Basic UDI-DI
- 697209192GDWZ19N6 EUDAMED
- Direct Marketing DI
- 06942382610962 EUDAMED
- EMDN Code
- U0602 UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC 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 Zebra Nitinol Core Guidewire With Hydrophilic Tip 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 | 697209192GDWZ19N6 | 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 64a611ca-6f69-40c2-b061-b44c423ba53a 61 fields · synced Jun 19, 2026