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Orthodontic Stainless Steel Wires
EUDAMEDClass IIa (EU MDR)
Ref 3512-1925Model Rectangular Wires
Identity
- Trade Name
- Orthodontic Stainless Steel Wires EUDAMED
- Device Name
- Orthodontic Stainless Steel Wires EUDAMED
- Model / Reference
- Rectangular Wires EUDAMED3512-1925 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942054740690 EUDAMED
- Basic UDI-DI
- 697039438104KQ 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 Stainless Steel Wires 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 | 697039438104KQ | 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 dd8951b0-6921-4a85-bd5c-385baf072a6f 61 fields · synced Oct 6, 2026