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Orthodontic Archwire
EUDAMEDClass IIa (EU MDR)
Ref Stainless Steel archwires 12 upper OvoidModel stainless steel
Identity
- Trade Name
- Orthodontic Archwire EUDAMED
- Device Name
- Orthodontic Archwires EUDAMED
- Model / Reference
- stainless steel EUDAMEDStainless Steel archwires 12 upper Ovoid EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974435051781 EUDAMED
- Basic UDI-DI
- 697443505AW05JD 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 Class IIa archwires designed for precise and effective tooth alignment in orthodontic treatment. Made from high-quality stainless steel, this device features a unique LAX (Latex) specification of 0 and is classified as a Class IIa product. With its simple and intuitive design, the Orthodontic Archwire is an ideal choice for professionals seeking to improve patients' smiles.
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 | 697443505AW05JD | 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 e62c8aac-9418-426f-9918-d329ef2c607a 61 fields · synced Jun 24, 2026