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ORTHODONTIC WIRES Remove nomenclature code
EUDAMEDClass IIa (EU MDR)
Ref SE012001Model Niti WiresRef SE02172201
Identity
- Trade Name
- ORTHODONTIC WIRES Remove nomenclature code EUDAMED
- Device Name
- Orthodontic Archwires EUDAMED
- Model / Reference
- Niti Wires EUDAMEDSE012001 EUDAMEDSE02172201 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957067000266 EUDAMED06957067000372 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
ORTHODONTIC WIRES Remove nomenclature code 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 (2)
- EUDAMED 0b8052d7-3d72-47f0-bdad-26e499fbed2d 61 fields · synced Jun 20, 2026
- EUDAMED 889fe590-fc54-49e7-b9aa-fd38ae971ca2 61 fields · synced May 17, 2026