Identity
- Device Name
- Orthodontic Wires and Springs EUDAMED
- Model / Reference
- 1313NEP16256A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719881561789 EUDAMED
- Basic UDI-DI
- 47198815613VN EUDAMED
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France 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 and Springs by MEM Dental Technology Co., 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 | 47198815613VN | Class IIa | Active |
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Manufacturer
- Manufacturer
- MEM Dental Technology Co., Ltd
- EUDAMED SRN
- TW-MF-000003514
- Authorised Representative
- Meimen Engineering Manufacturer AB SE-AR-000002115
Sources (1)
- EUDAMED 1f4b9551-276f-4f84-8729-1cea007f4b59 61 fields · synced Jun 18, 2026