Identity
- Device Name
- Orthodontic Archwires EUDAMED
- Model / Reference
- IP6112-1800-HT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941673538848 EUDAMED
- Basic UDI-DI
- 69416735WRS735YN EUDAMED
- Direct Marketing DI
- 06941673538848 EUDAMED
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Portugal 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
Orthodontic Archwires is a Class IIa orthodontic archwire designed for the permanent straightening of teeth. These wires are made from stainless steel, have an endocrine disruptor level of 0, and are intended for use in patients who require significant tooth movement.
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 | 69416735WRS735YN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Astar Orthodontics Inc.
- EUDAMED SRN
- CN-MF-000028647
- Authorised Representative
- BIO CONCEPT, UNIPESSOAL, LDA PT-AR-000021480
Sources (1)
- EUDAMED a76448cd-f8fb-4e28-a7a6-1908c92ac209 61 fields · synced Jul 9, 2026