Identity
- Trade Name
- Non-Vascular Guidewires EUDAMED
- Device Name
- Non-Vascular Guidewires EUDAMED
- Model / Reference
- FST-GW-88--B1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957024900233 EUDAMED
- Basic UDI-DI
- 695702495004JP EUDAMED
- Direct Marketing DI
- 06957024900233 EUDAMED
- EMDN Code
- C04010202 CORONARY ARTERY THERAPEUTIC GUIDEWIRES, NON-HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Non-Vascular Guidewires by Foresight Technology 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 | 695702495004JP | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Foresight Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009708
- Authorised Representative
- Creo Medical, S.L.U. ES-AR-000001355
Sources (1)
- EUDAMED 07ef3a5c-a4b9-4bed-a8fe-9eea7440b6a1 61 fields · synced Jun 18, 2026