Identity
- Trade Name
- Galvano NEO EUDAMED
- Device Name
- Galvanische Goldbaeder EUDAMED
- Model / Reference
- 40014 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260649891889 EUDAMED
- Basic UDI-DI
- 426064989GalvGoldbaeder4K EUDAMED
- Direct Marketing DI
- 04260649891889 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
Galvano NEO by WIELAND Edelmetalle GmbH — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental casting non-noble alloy.
- Micronium Exclusiv, sample — Schütz Dental GmbH · Class II
- EC 610 — Cookson Precious Metals Ltd · Class IIa
- TICONIUM — CMP INDUSTRIES LLC · Class II
- Zirlux — HENRY SCHEIN, INC. · Class II
- NOBILIUM — CMP INDUSTRIES LLC · Class II
- System Ti5-Blank 98, 5 x 25 mm — Adentatec GmbH Competence in Dental · Class II
- Magnum Solare — Mesa Italia S.r.l. · Class IIa
- NIRANIUM — CMP INDUSTRIES LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- WIELAND Edelmetalle GmbH
- EUDAMED SRN
- DE-MF-000006997
Sources (1)
- EUDAMED 76e1a6e3-8cb2-4c9b-8c93-646897b9319b 61 fields · synced Jun 18, 2026