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Q010405
EUDAMEDClass IIa (EU MDR)
Ref SE11142501Model Niti WiresRef SE08172502Ref SE03202001DRef SE032001D
Identity
- Trade Name
- Q010405 EUDAMED
- Device Name
- Orthodontic Archwires EUDAMED
- Model / Reference
- Niti Wires EUDAMEDSE11142501 EUDAMEDSE08172502 EUDAMEDSE03202001D EUDAMEDSE032001D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957067002451 EUDAMED06957067003533 EUDAMED06957067032878 EUDAMED06957067032830 EUDAMED
- Basic UDI-DI
- 695706700003-0373FD EUDAMED
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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
Q010405 by Innovative Material and Devices, 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 | 695706700003-0373FD | Class IIa | Active |
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Manufacturer
- Manufacturer
- Innovative Material and Devices, Inc
- EUDAMED SRN
- CN-MF-000002280
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (4)
- EUDAMED ba2ece58-8680-47bd-93b6-970bd29fb11f 61 fields · synced Jul 24, 2026
- EUDAMED ad90fa7a-fd08-47e5-9cf7-d85764cfc3e9 61 fields · synced May 17, 2026
- EUDAMED 28a86187-05d9-4138-ab8b-8e9a0a061bb6 61 fields · synced May 17, 2026
- EUDAMED 3469715b-4432-491b-abe8-19f9c12e3f9d 61 fields · synced May 18, 2026