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Dental Alloys
EUDAMEDClass IIa (EU MDR)
Ref 06975168470030Model Audental 22Ref 06975168470054Model Audental 04Ref 06975168470078Model Audental 40Ref 06975168478937Model 傲丹特TiRef 06975168470047Model Audental 03Ref 06975168478982Model 傲丹特UltraRef 06975168470122Model Audental Pt15Ref 06975168470023Model Audental 86
Identity
- Trade Name
- Dental Alloys EUDAMED
- Device Name
- Dental Alloys EUDAMED
- Model / Reference
- Audental 22 EUDAMED06975168470030 EUDAMEDAudental 04 EUDAMED06975168470054 EUDAMEDAudental 40 EUDAMED06975168470078 EUDAMED傲丹特Ti EUDAMED06975168478937 EUDAMEDAudental 03 EUDAMED06975168470047 EUDAMED傲丹特Ultra EUDAMED06975168478982 EUDAMEDAudental Pt15 EUDAMED06975168470122 EUDAMEDAudental 86 EUDAMED06975168470023 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975168470030 EUDAMED06975168470054 EUDAMED06975168470078 EUDAMED06975168478937 EUDAMED06975168470047 EUDAMED06975168478982 EUDAMED06975168470122 EUDAMED06975168470023 EUDAMED
- Basic UDI-DI
- B-06975168470030 EUDAMEDB-06975168470054 EUDAMEDB-06975168470078 EUDAMEDB-06975168478937 EUDAMEDB-06975168470047 EUDAMEDB-06975168478982 EUDAMEDB-06975168470122 EUDAMEDB-06975168470023 EUDAMED
- EMDN Code
- Q010601 DENTAL ALLOYS EUDAMEDQ01010101 AMALGAMS FOR RESTORATIVE DENTISTRY 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
Dental Alloys by Audental Bio-Material Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-06975168470030 | 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 (8)
- EUDAMED 8bd203f2-d434-4ef8-8bb8-cf912a787cfa 61 fields · synced Jul 31, 2026
- EUDAMED 975d4c39-6bc6-4dba-8b4e-b71d9457d929 61 fields · synced May 17, 2026
- EUDAMED bd7d05d8-ab32-47bb-bf6e-ce70e3c8c08f 61 fields · synced May 17, 2026
- EUDAMED b7e7bcfa-84b4-44f1-80a7-edbd5d1fd812 61 fields · synced May 17, 2026
- EUDAMED c312d9a7-f6de-44d3-8f32-8daa8314eb52 61 fields · synced May 17, 2026
- EUDAMED e162df1c-086f-4262-b2bd-4340d3085f10 61 fields · synced May 18, 2026
- EUDAMED 0a0326f7-9263-408a-8dcf-f57be7537d11 61 fields · synced May 18, 2026
- EUDAMED effb5dd1-ed05-41e4-bec4-41d21b8c0960 61 fields · synced May 18, 2026