Identity
- Trade Name
- Guidewire EUDAMED
- Device Name
- HYDROWIRE Guidewire EUDAMED
- Model / Reference
- HW260-025-AG EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904314400497 EUDAMED
- Basic UDI-DI
- B-18904314400497 EUDAMED
- EMDN Code
- C04020101 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, HYDROPHILIC EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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
Guidewire by Advanced LifeSciences Pvt. Ltd. — Class IIa — 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-18904314400497 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Advanced LifeSciences Pvt. Ltd.
- EUDAMED SRN
- IN-MF-000016421
- Authorised Representative
- CMC Medical Devices & Drugs SL ES-AR-000000293
Sources (1)
- EUDAMED e394fcce-c1d7-47cb-9059-8a38f62f1921 61 fields · synced Jun 17, 2026