Identity
- Trade Name
- Amalgam Well EUDAMED
- Device Name
- Amalgam Well EUDAMED
- Model / Reference
- MD2810 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G520MD28100 EUDAMED
- Basic UDI-DI
- B-G520MD28100 EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
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
Amalgam Well by Medspo — Class I — 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-G520MD28100 | Class I | Active |
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Manufacturer
- Manufacturer
- Medspo
- EUDAMED SRN
- PK-MF-000037594
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 2953f6ab-306f-425c-813d-a4f5e90ce42f 61 fields · synced Jun 19, 2026