Identity
- Device Name
- Guide Wires EUDAMED
- Model / Reference
- 612132 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956014421321 EUDAMED
- Basic UDI-DI
- B-06956014421321 EUDAMED
- EMDN Code
- C04020102 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye 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 Wires by Shunmei Medical 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-06956014421321 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Shunmei Medical Co., Ltd
- EUDAMED SRN
- CN-MF-000001160
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED d0e6767a-fb16-41f8-a143-292bfcc13a76 61 fields · synced Sep 17, 2026