Identity
- Trade Name
- AMALGAM WELL EUDAMED
- Device Name
- AMALGAM CARRIER REGULAR/LARGE 20CM EUDAMED
- Model / Reference
- AMALGAM CARRIER EUDAMEDD-120-856 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08961104041974 EUDAMED
- Basic UDI-DI
- 896110404AMALGAMCLASSIDP EUDAMED
- EMDN Code
- L15900699 DENTAL MATERIAL PROCESSING INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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 Mark One Surgical — 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 | 896110404AMALGAMCLASSIDP | Class I | Active |
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Manufacturer
- Manufacturer
- Mark One Surgical
- EUDAMED SRN
- PK-MF-000031202
- Authorised Representative
- KHANG BAO INTERNATIONAL KFT HU-AR-000034102
Sources (1)
- EUDAMED 5edc01dc-fc68-4453-9ed1-596ee9c2664e 61 fields · synced Jun 19, 2026