Identity
- Trade Name
- Aristaloy 21 capsules 2 Spill EUDAMED
- Device Name
- Dental Amalgam EUDAMED
- Model / Reference
- ZLHC 200 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15060501370660 EUDAMED
- Basic UDI-DI
- 5057531dentalamalgamCR EUDAMED
- EMDN Code
- Q01010101 AMALGAMS FOR RESTORATIVE DENTISTRY EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Northern Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Aristaloy 21 capsules 2 Spill 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 090d65f1-e1f2-46b6-8c4c-e7785daf8263 61 fields · synced Jun 18, 2026