Identity
- Trade Name
- Aristaloy Bulk powder EUDAMED
- Device Name
- Dental Amalgam EUDAMED
- Model / Reference
- ZLG 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15060501370561 EUDAMED
- Basic UDI-DI
- 5057531dentalamalgamCR EUDAMED
- EMDN Code
- Q01010101 AMALGAMS FOR RESTORATIVE DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
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
Aristaloy Bulk powder by Cookson Precious Metals Ltd — Class IIa — 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 | 5057531dentalamalgamCR | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cookson Precious Metals Ltd
- EUDAMED SRN
- GB-MF-000008770
- Authorised Representative
- Cookson Drijfhout BV NL-AR-000006890
Sources (1)
- EUDAMED 2f69b1da-1063-43e1-8128-618b114856d9 61 fields · synced Jun 17, 2026