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Urologic Guide Wire
EUDAMEDClass IIa (EU MDR)
Ref H06-S-038-150MModel Metal type
Identity
- Trade Name
- Urologic Guide Wire EUDAMED
- Device Name
- Urologic Guide Wire EUDAMED
- Model / Reference
- Metal type EUDAMEDH06-S-038-150M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942214110011 EUDAMED
- Basic UDI-DI
- 697197678DXACE0503W4 EUDAMED
- EMDN Code
- U0602 UROLOGICAL GUIDEWIRES, NOT 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 | 697197678DXACE0503W4 | 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 c016645e-9aaa-44ea-8061-4035296986f4 61 fields · synced Jun 18, 2026