Identity
- Trade Name
- ZCem Phos - Zinc Phos Cem 90g/30ml EUDAMED
- Device Name
- GI Luting cement / Zinc Polycarboxylate cement EUDAMED
- Model / Reference
- 'AH0600-P EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060446604878 EUDAMED
- Basic UDI-DI
- 5056009120268SX EUDAMED
- EMDN Code
- Q0101010299 TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER 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
Category: Dental composite resin
ZCem Phos - Zinc Phos Cem 90g/30ml by Advanced Healthcare Ltd. — 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 | 5056009120268SX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Advanced Healthcare Ltd.
- EUDAMED SRN
- GB-MF-000002771
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 117a44fb-8da1-4a26-91a3-cea1127780ba 61 fields · synced Jul 15, 2026