Identity
- Device Name
- Micro Guidewire EUDAMED
- Model / Reference
- 627436 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956014474365 EUDAMED
- Basic UDI-DI
- B-06956014474365 EUDAMED
- EMDN Code
- C04020101 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class III 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
Micro Guidewire by Shunmei Medical Co., Ltd — Class III — 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-06956014474365 | Class III | 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 94fe4217-69ad-4d9b-9d31-721201a6ab0b 61 fields · synced Sep 18, 2026