Identity
- Trade Name
- AMALGAM CARRIER 2.5mm EUDAMED
- Device Name
- AMALGAM CARRIER 2.5mm EUDAMED
- Model / Reference
- 1020-8 EUDAMED
Identifiers
- Primary DI / UDI-DI
- D123102080 EUDAMED
- Basic UDI-DI
- ++D12310208BJ EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER 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 CARRIER 2.5mm 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 | ++D12310208BJ | 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 2f135cd4-0ce9-40b2-940d-c758c111a256 61 fields · synced Jun 18, 2026