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Orthodontic Arch Wires
EUDAMEDClass IIa (EU MDR)
Ref 012 lowerModel NiTi Ref 016 upperRef 016 lowerRef 014 upperRef Niti Open Spring 12”Ref 016*022 upper
Identity
- Trade Name
- Orthodontic Arch Wires EUDAMED
- Device Name
- Orthodontic Archwires EUDAMED
- Model / Reference
- NiTi EUDAMED012 lower EUDAMED016 upper EUDAMED016 lower EUDAMED014 upper EUDAMEDNiti Open Spring 12” EUDAMED016*022 upper EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942665508962 EUDAMED06942665509013 EUDAMED06942665509006 EUDAMED06942665508993 EUDAMED06942665509044 EUDAMED06942665509037 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
Orthodontic Arch Wires by Creative Dental — 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 | 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 (6)
- EUDAMED c2158dd7-4888-4047-ac45-dd53b7f0f63d 61 fields · synced Jul 22, 2026
- EUDAMED 900f5321-bf59-417c-bc53-75bc8a1bf3d6 61 fields · synced May 16, 2026
- EUDAMED 46b88903-ab58-45a5-8b6c-b06affd12614 61 fields · synced May 17, 2026
- EUDAMED 69ec45a7-5ace-46a1-be76-1447ce3b3f1b 61 fields · synced May 18, 2026
- EUDAMED d9a095e9-cf98-420b-acf0-e63bcec3b06a 61 fields · synced May 18, 2026
- EUDAMED a198ef3c-4752-4323-9e0b-6d1486743a99 61 fields · synced May 19, 2026