Identity
- Device Name
- Transradial Introducer Sets EUDAMED
- Model / Reference
- 42.10.20205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938820549772 EUDAMED
- Basic UDI-DI
- B-06938820549772 EUDAMED
- EMDN Code
- C0504 ARTERIAL INTRODUCTION SETS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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
Category: Interventional radiology percutaneous-access kit, single-use
Transradial Introducer Sets by SCW Medicath Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-06938820549772 | Class IIa | Active |
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Manufacturer
- Manufacturer
- SCW Medicath Ltd.
- EUDAMED SRN
- CN-MF-000019140
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 0c773f47-84d8-463a-8598-2b9c47ed4c71 61 fields · synced Jun 17, 2026