Identity
- Device Name
- Balloon Inflation Device EUDAMED
- Model / Reference
- 42.04.30029 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06938820524403 EUDAMED
- Basic UDI-DI
- 69388205000000000000002ZN EUDAMED
- EMDN Code
- R03020202 SELF-INFLATING VENTILATION BALLOONS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Poland 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
Balloon Inflation Device by SCW Medicath Ltd. — Class I — 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 | 69388205000000000000002ZN | 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 0b9d6d10-3331-4156-b6e2-e05913f32050 61 fields · synced Jul 15, 2026