Identity
- Model / Reference
- LOC EUDAMED25031 EUDAMED25031_EM EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08445594000319 EUDAMED08445594000739 EUDAMED
- Basic UDI-DI
- 8445594_LOCALIZ_9S EUDAMED
- EMDN Code
- Q010207 DENTAL IMPRESSION DEVICES FOR PROSTHETIC DENTISTRY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
25031 by Em Exact, S.a. — 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 | 8445594_LOCALIZ_9S | Class I | Active |
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Manufacturer
- Manufacturer
- Em Exact, S.a.
- EUDAMED SRN
- ES-MF-000010830
Sources (2)
- EUDAMED 58779176-3a96-4d60-ae29-537967e878d4 61 fields · synced Jul 30, 2026
- EUDAMED 8da7fa6f-16fe-4431-99b3-e085bc47c57a 61 fields · synced May 18, 2026