Identity
- Trade Name
- ALFASHIELD - GEL ΥΠΕΡΗΧΟΥ 5000g EUDAMED
- Device Name
- ULTRASOUND GEL EUDAMED
- Model / Reference
- GEL-AS-002 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05206355032818 EUDAMED
- Basic UDI-DI
- 5206355USGL3T EUDAMED
- EMDN Code
- Z11040185 ULTRASOUND SCANNERS - CONSUMABLES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Greece EUDAMED
Clinical & Handling
Sterile
No
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
ALFASHIELD - GEL ΥΠΕΡΗΧΟΥ 5000g by Καραμπινης Medical A.e. — 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 | 5206355USGL3T | Class I | Active |
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Manufacturer
- Manufacturer
- Καραμπινης Medical A.e.
- EUDAMED SRN
- GR-MF-000023526
Sources (1)
- EUDAMED a9239efa-f486-4be2-a989-ccc6cc28e3ab 61 fields · synced Jul 9, 2026