Identity
- Trade Name
- Zolid Lunaris B1 98x12 EUDAMED
- Device Name
- Zirconia class 5 EUDAMED
- Model / Reference
- 768586 EUDAMED
Identifiers
- Primary DI / UDI-DI
- E4947685861 EUDAMED
- Basic UDI-DI
- ++E494LUNAGS EUDAMED
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
Zolid Lunaris B1 98x12 by Amann Girrbach AG — 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 | ++E494LUNAGS | Class IIa | Active |
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Manufacturer
- Manufacturer
- Amann Girrbach AG
- EUDAMED SRN
- AT-MF-000000252
Sources (1)
- EUDAMED 4bb8dc46-d9c3-46f3-991f-0ae35476ae99 61 fields · synced Jul 26, 2026