Identity
- Trade Name
- Galvano NEO EUDAMED
- Device Name
- Galvanische Goldbaeder EUDAMED
- Model / Reference
- 40013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260649891896 EUDAMED
- Basic UDI-DI
- 426064989GalvGoldbaeder4K EUDAMED
- Direct Marketing DI
- 04260649891896 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
Galvano NEO by WIELAND Edelmetalle GmbH — 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 | 426064989GalvGoldbaeder4K | Class IIa | Active |
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Manufacturer
- Manufacturer
- WIELAND Edelmetalle GmbH
- EUDAMED SRN
- DE-MF-000006997
Sources (1)
- EUDAMED 6efb0e4a-e1af-4c38-ac12-bb60d89236b6 61 fields · synced Jun 17, 2026