Identity
- Device Name
- Guide wire hydrophilic coating EUDAMED
- Model / Reference
- GWO-35-150A EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972197830750 EUDAMED
- Basic UDI-DI
- B-06972197830750 EUDAMED
- EMDN Code
- C04020101 PERIPHERAL VASCULAR DIAGNOSTIC 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Guide wire hydrophilic coating by Shenzhen MicroApproach Medical Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06972197830750 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shenzhen MicroApproach Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000032012
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED d816f801-cbc1-4970-89b9-ad0b75be4475 61 fields · synced Jun 19, 2026