Identity
- Trade Name
- GI Extra Luting EUDAMED
- Device Name
- GI Luting cement / Zinc Polycarboxylate cement EUDAMED
- Model / Reference
- 432X1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056009102752 EUDAMED
- Basic UDI-DI
- 5056009120268SX EUDAMED
- EMDN Code
- Q01010106 DENTAL RESTORATION GLASS IONOMERS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Malta 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
GI Extra Luting by Advanced Healthcare Ltd. — 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 | 5056009120268SX | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Healthcare Ltd.
- EUDAMED SRN
- GB-MF-000002771
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED a2a9e965-e1d9-41ba-88cc-2955390e2baa 61 fields · synced Jun 19, 2026