Identity
- Trade Name
- Dental alloys EUDAMED
- Device Name
- Dental Alloys EUDAMED
- Model / Reference
- Audental 90 EUDAMED06975168470016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975168470016 EUDAMED
- Basic UDI-DI
- B-06975168470016 EUDAMED
- EMDN Code
- Q010601 DENTAL ALLOYS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental casting non-noble alloy
Dental alloys by Audental Bio-Material Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06975168470016 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Audental Bio-Material Co., Ltd.
- EUDAMED SRN
- CN-MF-000023257
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 25a447e3-a41f-4137-8457-9b927eb49f01 61 fields · synced Jun 18, 2026