Identity
- Trade Name
- i-ZOE N EUDAMED
- Device Name
- Resin modified zinc oxide-eugenol cement EUDAMED
- Model / Reference
- ICEKP EUDAMEDICETP EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04772178003355 EUDAMED04772178003362 EUDAMED
- Basic UDI-DI
- 4772178ML-RMZOECKV 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
Yes
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
i-ZOE N by UAB "Medicinos linija" — Class IIa — 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 | 4772178ML-RMZOECKV | Class IIa | Active |
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Manufacturer
- Manufacturer
- UAB "Medicinos linija"
- EUDAMED SRN
- LT-MF-000002719
Sources (2)
- EUDAMED 1aa99acc-2f3a-41c4-9bc3-0ac7f482ba6a 61 fields · synced Oct 6, 2026
- EUDAMED cbc11f82-2cd1-48c4-9271-833738d8c2c3 61 fields · synced May 17, 2026