Identity
- Trade Name
- SURGIWIRE Guidewire EUDAMED
- Device Name
- SURGIWIRE Guidewire EUDAMED
- Model / Reference
- SWST260-021-P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 18904314400121 EUDAMED
- Basic UDI-DI
- B-18904314400121 EUDAMED
- EMDN Code
- C04020102 PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-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
SURGIWIRE 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-18904314400121 | 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 829943d3-15e4-4d0b-8661-2efc07eaf225 61 fields · synced Jul 14, 2026