Identity
- Device Name
- Zebra guide wire EUDAMED
- Model / Reference
- ZWO-32-150P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06972197831054 EUDAMED
- Basic UDI-DI
- B-06972197831054 EUDAMED
- EMDN Code
- C04020101 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa 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
Zebra guide wire 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-06972197831054 | 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 c261568f-9547-40e4-9c80-fe5eaf3e20da 61 fields · synced Jun 18, 2026