Identity
- Trade Name
- Image EUDAMED
- Device Name
- IMAGE ALGINATE EUDAMED
- Model / Reference
- 27427DX EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594747005944 EUDAMED
- Basic UDI-DI
- 8594747100001228 EUDAMED
- EMDN Code
- Q01020101 DENTAL IMPRESSION ALGINATES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Czechia 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
Image, a medical device used in dentistry to provide a safe and effective way to align teeth. By using Image, patients can experience a more aesthetically pleasing smile while reducing the risk of dental work-related complications.
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 | 8594747100001228 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SpofaDental a.s.
- EUDAMED SRN
- CZ-MF-000000945
Sources (1)
- EUDAMED c9ea7cf6-347d-4f70-a57a-686d96361133 61 fields · synced Jul 14, 2026