Identity
- Trade Name
- Guiding Catheter EUDAMED
- Device Name
- Guiding Catheter EUDAMED
- Model / Reference
- GC-5F-125-VTK EUDAMED42.22.80007 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938820561354 EUDAMED
- Basic UDI-DI
- 69388205000000000000005ZU EUDAMED
- EMDN Code
- C0104020204 PERIPHERAL ANGIOGRAPHY GUIDE CATHETERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Greece 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
Guiding Catheter by SCW Medicath 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 | 69388205000000000000005ZU | Class IIa | Active |
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Manufacturer
- Manufacturer
- SCW Medicath Ltd.
- EUDAMED SRN
- CN-MF-000019140
- Authorised Representative
- Eunitor GmbH DE-AR-000005081
Sources (1)
- EUDAMED 476cffed-ba40-4016-8b3d-2face24087ab 61 fields · synced Jun 19, 2026