Identity
- Trade Name
- Image EUDAMED
- Device Name
- IMAGE ALGINATE EUDAMED
- Model / Reference
- 27460 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08594747005937 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 by SpofaDental a.s. — 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 | 8594747100001228 | Class I | Active |
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Manufacturer
- Manufacturer
- SpofaDental a.s.
- EUDAMED SRN
- CZ-MF-000000945
Sources (1)
- EUDAMED 9d354246-ec36-434b-90e3-0bf7092ac915 61 fields · synced Jul 10, 2026