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Orthodontic Archwires
EUDAMEDClass I (EU MDR)
Ref SE01161602DModel Root Canal Files-for hand
Identity
- Trade Name
- Orthodontic Archwires EUDAMED
- Device Name
- Root Canal Files EUDAMED
- Model / Reference
- Root Canal Files-for hand EUDAMEDSE01161602D EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06957067030935 EUDAMED
- Basic UDI-DI
- 695706705118-5232NM EUDAMED
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
Classification
- Device Class
- Class I 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 Archwires by Innovative Material and Devices, Inc — Class I — 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 | 695706705118-5232NM | Class I | 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 c19d01eb-6458-4749-80ec-42dd990fa3e5 61 fields · synced Jun 18, 2026