Identity
- Device Name
- Balloon Inflation Devices EUDAMED
- Model / Reference
- 6938820549390 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938820549390 EUDAMED
- Basic UDI-DI
- B-06938820549390 EUDAMED
- EMDN Code
- C0104010280 INTERVENTIONAL CORONARY ANGIOGRAPHY DEVICES - ACCESSORIES EUDAMED
Classification
- Device Class
- Class I 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
Balloon Inflation Devices by SCW Medicath Ltd. — Class I — 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-06938820549390 | Class I | 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 a777820c-4d05-4314-a74f-38ebf91d1267 61 fields · synced Jul 18, 2026