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Orthodontic Wires
EUDAMEDClass IIa (EU MDR)
Ref SE02172502Model Niti WiresRef SE01172502Ref SE01162201Ref SE021401Ref SE021602Ref SE021202Ref SE021802Ref SE01182501Ref SE02162201Ref SE01172501Ref SE021402Ref SE02182502Ref SE011802
Identity
- Trade Name
- ORTHODONTIC WIRES EUDAMED
- Device Name
- Orthodontic Archwires EUDAMED
- Model / Reference
- Niti Wires EUDAMEDSE02172502 EUDAMEDSE01172502 EUDAMEDSE01162201 EUDAMEDSE021401 EUDAMEDSE021602 EUDAMEDSE021202 EUDAMEDSE021802 EUDAMEDSE01182501 EUDAMEDSE02162201 EUDAMEDSE01172501 EUDAMEDSE021402 EUDAMEDSE02182502 EUDAMEDSE011802 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957067000402 EUDAMED06957067000204 EUDAMED06957067000174 EUDAMED06957067000297 EUDAMED06957067000327 EUDAMED06957067000280 EUDAMED06957067000426 EUDAMED06957067000235 EUDAMED06957067000358 EUDAMED06957067000198 EUDAMED06957067000303 EUDAMED06957067000464 EUDAMED06957067000228 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 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 (13)
- EUDAMED 4c31829a-b041-4000-a8be-32bdca307df4 61 fields · synced Sep 18, 2026
- EUDAMED 8331aba0-fa9d-4d8d-929b-2636e2302090 61 fields · synced May 16, 2026
- EUDAMED 41a89912-d46c-497e-864e-e078b3de77e4 61 fields · synced May 16, 2026
- EUDAMED ebfb9261-5e2c-4435-bad7-2116415b0402 61 fields · synced May 17, 2026
- EUDAMED a56940b5-3caa-428f-b7a3-e5dcf73b010e 61 fields · synced May 17, 2026
- EUDAMED f3eeb850-971b-4ca5-b51b-7fd5295aa2ba 61 fields · synced May 17, 2026
- EUDAMED 6b726f4f-db59-40ae-b659-0eb249f10fea 61 fields · synced May 17, 2026
- EUDAMED 5555850a-6e1a-482d-b177-d2f94e3659e6 61 fields · synced May 17, 2026
- EUDAMED db0a3469-f051-4b13-9c71-b9ad1a458bef 61 fields · synced May 17, 2026
- EUDAMED 839e84c4-cc7d-4e51-bac9-c6ce9f642999 61 fields · synced May 17, 2026
- EUDAMED eda3628d-0d88-48ab-8e34-9c4294540dc7 61 fields · synced May 18, 2026
- EUDAMED 57cccc5d-bf06-4829-ac92-39f0e976e46a 61 fields · synced May 18, 2026
- EUDAMED b906f9d4-9b4c-4d3e-b882-41ea782bcdec 61 fields · synced May 19, 2026