Identity
- Trade Name
- AMALGAM WELL EUDAMED
- Device Name
- AMALGAM WELL 36mm EUDAMED
- Model / Reference
- 1020-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D1231020150 EUDAMED
- Basic UDI-DI
- ++D123102015VL EUDAMED
- EMDN Code
- L15900601 DENTAL MATERIAL PROCESSING MILLS, REUSABLE EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Amalgam Well by Dental Expert — Class I — 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 | ++D123102015VL | Class I | Active |
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Manufacturer
- Manufacturer
- Dental Expert
- EUDAMED SRN
- PK-MF-000024595
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED cf3301ae-1942-4568-b9b4-4f111cf081e8 61 fields · synced Jun 19, 2026