Identity
- Trade Name
- Amalgam Well EUDAMED
- Device Name
- Amalgam Well EUDAMED
- Model / Reference
- AMALGAM WELL EUDAMEDCT-AW EUDAMED
Identifiers
- Primary DI / UDI-DI
- +G399CTAW0W EUDAMED
- Basic UDI-DI
- ++G399AMALGAMWELLED EUDAMED
- Direct Marketing DI
- +G399CTAW0W EUDAMED
- EMDN Code
- Q010302 DENTAL GRAFT DEVICES 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
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 Crosstex (private) Limited. — 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 | ++G399AMALGAMWELLED | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Crosstex (private) Limited.
- EUDAMED SRN
- PK-MF-000032784
- Authorised Representative
- ANTEX MEDI SOLUTION DE-AR-000008078
Sources (1)
- EUDAMED 12fb6c56-51df-4966-ba11-f53dbb1765a1 61 fields · synced Jun 19, 2026