Identity
- Device Name
- Micro Guidewire EUDAMED
- Model / Reference
- 633128 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06956014431283 EUDAMED
- Basic UDI-DI
- B-06956014431283 EUDAMED
- EMDN Code
- N0199 ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - OTHER 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-06956014431283 | 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 f747ae94-9f4d-4c9a-ae14-5248249682ef 61 fields · synced Sep 18, 2026