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Orthodontic NiTi Materials Archwires
EUDAMEDClass IIa (EU MDR)
Ref 103Model Rectangular Wires
Identity
- Device Name
- Orthodontic NiTi Materials Archwires EUDAMED
- Model / Reference
- Rectangular Wires EUDAMED103 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942054764375 EUDAMED
- Basic UDI-DI
- 697039438103KN EUDAMED
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Netherlands 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 NiTi Materials Archwires by Zhejiang Shinye Medical Technology Corp. , Ltd. — 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 | 697039438103KN | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Shinye Medical Technology Corp. , Ltd.
- EUDAMED SRN
- CN-MF-000023934
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED adbc63b9-3a03-4e4e-a7ae-9291e4bd747c 61 fields · synced Jun 18, 2026