Identity
- Trade Name
- Digital X-Ray Sensor Cover - Unodent EUDAMED
- Device Name
- Barrier Covers EUDAMED
- Model / Reference
- CVH150 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060111783181 EUDAMED
- Basic UDI-DI
- 50601117812535171VK EUDAMED
- EMDN Code
- T030199 COVERS, INSTRUMENTS AND EQUIPMENT - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Digital X-Ray Sensor Cover - Unodent by Astek Innovations 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 | 50601117812535171VK | Class I | Active |
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Manufacturer
- Manufacturer
- Astek Innovations Ltd
- EUDAMED SRN
- GB-MF-000013346
- Authorised Representative
- Young Microbrush Ireland Ltd IE-AR-000011249
Sources (1)
- EUDAMED 997082cc-98b0-493b-b3dc-13ec4492da4e 61 fields · synced Jul 12, 2026