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Urologic Guide Wire
EUDAMEDClass IIa (EU MDR)
Ref H06-J-035-180Model Hydrophilic type
Identity
- Trade Name
- Urologic Guide Wire EUDAMED
- Device Name
- Urologic Guide Wire EUDAMED
- Model / Reference
- Hydrophilic type EUDAMEDH06-J-035-180 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942214109725 EUDAMED
- Basic UDI-DI
- 697197678DXACE0501VY EUDAMED
- EMDN Code
- U0601 UROLOGICAL GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Urologic Guide Wire by Chengdu Daxan Innovative Medical Tech.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 | 697197678DXACE0501VY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Chengdu Daxan Innovative Medical Tech.Co., Ltd
- EUDAMED SRN
- CN-MF-000033805
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED fdd77c91-7b37-430c-8241-bafc88cdb816 61 fields · synced Jun 18, 2026