Identity
- Device Name
- Orthodontic Wires EUDAMED
- Model / Reference
- Lower EUDAMEDEE1040242 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944835152425 EUDAMED
- Basic UDI-DI
- B-06944835152425 EUDAMED
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Orthodontic Wires, a Class IIa orthodontic device, is designed to provide accurate and precise alignment of teeth. With its sterile design and implementation in clinical settings, it is an essential tool for orthodontists and dental professionals.
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-06944835152425 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Superline Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000027059
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (1)
- EUDAMED 1e0da65d-1383-4f93-a68d-a0fbfcab692b 61 fields · synced Aug 2, 2026