Identity
- Trade Name
- AGC® Glanzzusatz EUDAMEDAGC® Glanzzusatz Color EUDAMED
- Device Name
- Galvanische Goldbaeder EUDAMED
- Model / Reference
- 77-40-1004 EUDAMED77-40-1014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260649890585 EUDAMED04260649890622 EUDAMED
- Basic UDI-DI
- 426064989GalvGoldbaeder4K EUDAMED
- Direct Marketing DI
- 04260649890585 EUDAMED04260649890622 EUDAMED
- EMDN Code
- Q010601 DENTAL ALLOYS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Category: Dental casting non-noble alloy
AGC® Glanzzusatz by WIELAND Edelmetalle GmbH — 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 | 426064989GalvGoldbaeder4K | Class IIa | Active |
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Manufacturer
- Manufacturer
- WIELAND Edelmetalle GmbH
- EUDAMED SRN
- DE-MF-000006997
Sources (2)
- EUDAMED 08d648f8-219e-403f-abea-e647e86d95ef 61 fields · synced Jul 22, 2026
- EUDAMED 478a8eef-f92c-4475-8f50-addeb1721658 61 fields · synced May 19, 2026