Identity
- Trade Name
- Sunmed™ Guide wires EUDAMED
- Device Name
- Guide Wires EUDAMED
- Model / Reference
- SM-GW-3J35260HE-TP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06947358533801 EUDAMED
- Basic UDI-DI
- 694735850003L9 EUDAMED
- EMDN Code
- C04020101 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Sunmed™ Guide wires by Sunny Medical Device (Shenzhen) Co.Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 694735850003L9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sunny Medical Device (Shenzhen) Co.Ltd
- EUDAMED SRN
- CN-MF-000022722
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED 30035fdd-f7c6-400f-97a5-2810a506d9d8 61 fields · synced Oct 6, 2026