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Orthoshape NITI Super Elastic Square, Ovoid arch, Dimple wire, L.014"x.025"
EUDAMEDClass IIa (EU MDR)
Ref SE02142502DModel Niti Wires
Identity
- Trade Name
- Orthoshape NITI Super Elastic Square,Ovoid arch,Dimple wire,L.014"x.025" EUDAMED
- Device Name
- Orthodontic Archwires EUDAMED
- Model / Reference
- Niti Wires EUDAMEDSE02142502D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957067031611 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
Orthoshape NITI Super Elastic Square, Ovoid arch, Dimple wire, L.014"x.025" by Innovative Material and Devices, Inc — Class IIa — MDR — listed in EUDAMED
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 (1)
- EUDAMED 7300d7e9-e35c-4d7e-aa74-0290e1594ebf 61 fields · synced Aug 1, 2026