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Non-Vascular Guidewires
EUDAMEDClass IIa (EU MDR)
Ref FST-GW-80--C2Ref FST-GW-63--C1Ref FST-GW-63--C2Ref FST-GW-88--A1Ref FST-GW-63--B1Ref FST-GW-63--C3
Identity
- Trade Name
- Non-Vascular Guidewires EUDAMED
- Device Name
- Non-Vascular Guidewires EUDAMED
- Model / Reference
- FST-GW-80--C2 EUDAMEDFST-GW-63--C1 EUDAMEDFST-GW-63--C2 EUDAMEDFST-GW-88--A1 EUDAMEDFST-GW-63--B1 EUDAMEDFST-GW-63--C3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957024906136 EUDAMED06957024900325 EUDAMED06957024906129 EUDAMED06957024900554 EUDAMED06957024900165 EUDAMED06957024906150 EUDAMED
- Basic UDI-DI
- 695702495009JZ EUDAMED695702495005JR EUDAMED695702495008JX EUDAMED695702495002JK EUDAMED695702495003JM EUDAMED695702495011JL EUDAMED
- Direct Marketing DI
- 06957024906136 EUDAMED06957024900325 EUDAMED06957024906129 EUDAMED06957024900554 EUDAMED06957024900165 EUDAMED06957024906150 EUDAMED
- EMDN Code
- C04010201 CORONARY ARTERY THERAPEUTIC GUIDEWIRES, HYDROPHILIC EUDAMEDC04010202 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 | 695702495009JZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Foresight Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000009708
- Authorised Representative
- Creo Medical, S.L.U. ES-AR-000001355
Sources (6)
- EUDAMED 40deaf63-c61a-4a7c-8b51-28e9b38cbf88 61 fields · synced Jul 23, 2026
- EUDAMED c142a6dc-127e-4626-b2e6-aae8ced5c32c 61 fields · synced May 17, 2026
- EUDAMED 15ce3b36-5dcd-4e3e-9052-0c442228c81b 61 fields · synced May 17, 2026
- EUDAMED 0bcf1194-bc06-4ac0-bd6e-a56fa02270db 61 fields · synced May 18, 2026
- EUDAMED 37400101-c0ce-4367-8d43-c915601caaf2 61 fields · synced May 19, 2026
- EUDAMED b004d4dc-631f-483b-937a-108c5c412d89 61 fields · synced May 19, 2026