Identity
- Trade Name
- Drivewire 24 Guidewire EUDAMED
- Device Name
- Steerable Guidewire EUDAMED
- Model / Reference
- GWPP2422 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290015107365 EUDAMED
- Basic UDI-DI
- 7290015107GWPP1XV EUDAMED
- Direct Marketing DI
- 07290015107365 EUDAMED
- EMDN Code
- C04020299 PERIPHERAL VASCULAR GUIDEWIRES, THERAPEUTICAL - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany 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
Drivewire 24 Guidewire by Rapid Medical Ltd — Class III — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K233791 | Class III | Active |
| EUDAMED | European Union | CE/MDR | 7290015107GWPP1XV | Class III | Active |
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Manufacturer
- Manufacturer
- Rapid Medical Ltd
- EUDAMED SRN
- IL-MF-000012181
- Authorised Representative
- MedNet EC-REP III GmbH DE-AR-000011191
Sources (2)
- EUDAMED 2afb7248-c07a-42ca-bf16-e83cbc97ffd7 61 fields · synced Jul 16, 2026
- FDA 510(k) K233791 1 fields · synced May 18, 2026