Identity
- Trade Name
- i-FIX EUDAMED
- Device Name
- Glass Ionomer Luting Cement EUDAMED
- Model / Reference
- IIX10 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04772178004192 EUDAMED
- Basic UDI-DI
- 4772178ML-GILCUR EUDAMED
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Lithuania EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
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
Category: Dental composite resin
i-FIX by UAB "Medicinos linija" — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 4772178ML-GILCUR | Class IIa | Active |
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Manufacturer
- Manufacturer
- UAB "Medicinos linija"
- EUDAMED SRN
- LT-MF-000002719
Sources (1)
- EUDAMED 3ae2602a-0eb3-433f-acfb-47ca2da2028c 61 fields · synced Jun 18, 2026