Identity
- Trade Name
- Zfx™ Cobalt Chromium Eco 98x13,5 EUDAMED
- Device Name
- Metallische Disc/NEM-Aufbrennlegierung für normalexpandierende Keramik EUDAMED
- Model / Reference
- ZFX08000813 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260649890745 EUDAMED
- Basic UDI-DI
- 426064989MetallDiscYZ EUDAMED
- Direct Marketing DI
- 04260649890745 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
Yes
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
Zfx™ Cobalt Chromium Eco 98x13, 5 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 | 426064989MetallDiscYZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- WIELAND Edelmetalle GmbH
- EUDAMED SRN
- DE-MF-000006997
Sources (1)
- EUDAMED f80f6302-79c2-4b50-b116-1a23c22f9645 61 fields · synced Oct 7, 2026