Identity
- Trade Name
- ORTHODONTIC WIRES EUDAMED
- Device Name
- ORTHODONTIC WIRES EUDAMED
- Model / Reference
- EW-401-1825U EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974766253823 EUDAMED
- Basic UDI-DI
- 697476625EKS03PL 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 Zhejiang Eksen Medical 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 | 697476625EKS03PL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Zhejiang Eksen Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000034903
- Authorised Representative
- MedPath GmbH DE-AR-000000087
Sources (1)
- EUDAMED b7f7bdc8-cdaf-4e81-bfdb-3bcfa1476680 61 fields · synced Oct 6, 2026