Identity
- Trade Name
- 17ct Wires EUDAMED
- Device Name
- Orthodontic Materials EUDAMED
- Model / Reference
- ZWB 080 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15060501370523 EUDAMED
- Basic UDI-DI
- 5057531orthoRE EUDAMED
- EMDN Code
- Q010601 DENTAL ALLOYS 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
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
Category: Dental casting non-noble alloy
17ct Wires by Cookson Precious Metals Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 5057531orthoRE | 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 105fca5a-56f9-48a1-b651-d9f9d929f12f 61 fields · synced Jun 18, 2026