Identity
- Trade Name
- Bioker EUDAMED
- Model / Reference
- 60111001 EUDAMED60111040 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03831071385027 EUDAMED
- Basic UDI-DI
- 38310707AURODENT01XJ EUDAMED
- EMDN Code
- Q010601 DENTAL ALLOYS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Slovenia 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
Bioker by Zlatarna Celje d.o.o. — 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 | 38310707AURODENT01XJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zlatarna Celje d.o.o.
- EUDAMED SRN
- SI-MF-000021928
Sources (1)
- EUDAMED 385ab285-24a3-4d15-8467-58e28923dec4 61 fields · synced Jul 30, 2026