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Orthodontic Archwire
EUDAMEDClass IIa (EU MDR)
Ref Reverse curve NiTi archwire 016*022 upperModel NiTi
Identity
- Trade Name
- Orthodontic Archwire EUDAMED
- Device Name
- Orthodontic Archwires EUDAMED
- Model / Reference
- NiTi EUDAMEDReverse curve NiTi archwire 016*022 upper EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974435054836 EUDAMED
- Basic UDI-DI
- 697443505AW07JH EUDAMED
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Austria 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
The Orthodontic Archwire from Prolinx GmbH is a reliable and effective solution for correcting orthodontic issues. This revolutionary device features a unique design that allows for precise control over tooth movement, making it ideal for treating a range of dental conditions. With its advanced materials and manufacturing process, the Orthodontic Archwire provides unparalleled stability and durability.
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 | 697443505AW07JH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Creative Dental
- EUDAMED SRN
- CN-MF-000025975
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (1)
- EUDAMED 6a2a35e7-b01b-4909-9de9-113880e7b467 61 fields · synced Jul 29, 2026