Identity
- Trade Name
- Mouth Prop - Small Unodent EUDAMED
- Device Name
- Mouth Props - Assorted (Small, Medium and Large) EUDAMED
- Model / Reference
- 16499 EUDAMED16496UNODENT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060111783082 EUDAMED
- Basic UDI-DI
- 50601117842345ED EUDAMED
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany 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
Mouth Prop - Small 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 | 50601117842345ED | 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 118f3ca0-52ea-43ec-a0ba-7a6915e13bd9 61 fields · synced Jun 18, 2026