Identity
- Device Name
- Orthodontic Archwires EUDAMED
- Model / Reference
- IP6161-1200-O EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06941673551427 EUDAMED
- Basic UDI-DI
- 69416735WRS735YN EUDAMED
- Direct Marketing DI
- 06941673551427 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 by Astar Orthodontics Inc. — 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 | 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 (2)
- EUDAMED c83fe6c6-9f61-42a3-9f3a-68fa99bf9860 61 fields · synced Jun 18, 2026
- EUDAMED 3f691675-16c0-4a12-bd5a-b9d8924fe11d 61 fields · synced Jun 18, 2026