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Cuper Niti Archwire 35° Universal L 014 W/2
EUDAMEDClass IIa (EU MDR)
Ref 09.02.0914.3Model Archwires and WiresRef 09.04.0914.3
Identity
- Trade Name
- CUPER NITI ARCHWIRE 35° UNIVERSAL L 014 W/2 EUDAMEDCUPER NITI ARCHWIRE 35° BIOSLIDE UNIVERSAL L 014 W/2 EUDAMED
- Model / Reference
- Archwires and Wires EUDAMED09.02.0914.3 EUDAMED09.04.0914.3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07899439258532 EUDAMED07899439272002 EUDAMED
- Basic UDI-DI
- 7899439209JC EUDAMED
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Cuper Niti Archwire 35° Universal L 014 W/2 by Aditek do Brasil SA — 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 | 7899439209JC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Aditek do Brasil SA
- EUDAMED SRN
- BR-MF-000018793
- Authorised Representative
- EC Certification Service GmbH AT-AR-000006658
Sources (2)
- EUDAMED 5f66fea8-0f93-4505-b575-28a70067438d 61 fields · synced Jul 21, 2026
- EUDAMED 88c13900-1456-4567-b002-f56007dcfb66 61 fields · synced May 18, 2026