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Orthodontic Metal Brackets
EUDAMEDClass IIa (EU MDR)
Ref Galaxy 2.0 series MBT .018, LR3Model MBTRef standard bracket MBT0.022"Ref stangard bracket ROTH0.018"Model RothRef Galaxy 2.0 series Roth .022, UL5Ref Clever M, Self ligating, MBT 0.022" LL3Ref Galaxy 2.0 series MBT .018, LR3HRef Galaxy 2.0 series Roth .022, UL5H
Identity
- Trade Name
- Orthodontic Metal Brackets EUDAMED
- Device Name
- Orthodontic Metal Brackets EUDAMED
- Model / Reference
- MBT EUDAMEDGalaxy 2.0 series MBT .018, LR3 EUDAMEDstandard bracket MBT0.022" EUDAMEDRoth EUDAMEDstangard bracket ROTH0.018" EUDAMEDGalaxy 2.0 series Roth .022, UL5 EUDAMEDClever M, Self ligating, MBT 0.022" LL3 EUDAMEDGalaxy 2.0 series MBT .018, LR3H EUDAMEDGalaxy 2.0 series Roth .022, UL5H EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974435053051 EUDAMED06974435059794 EUDAMED06974435056137 EUDAMED06974435059749 EUDAMED06942665512099 EUDAMED
- Basic UDI-DI
- 697443505MR010FX EUDAMED697443505MR009GE EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS 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 Metal Brackets 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 | 697443505MR010FX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Creative Dental
- EUDAMED SRN
- CN-MF-000025975
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (8)
- EUDAMED 1d1894dc-86ec-4667-996a-ca10f8ac254c 61 fields · synced Jul 31, 2026
- EUDAMED ba66d10f-013e-4cb5-8cd8-1935261400a2 61 fields · synced May 17, 2026
- EUDAMED aee2aa55-303a-4182-94d3-f458a79debec 61 fields · synced May 17, 2026
- EUDAMED c2656e21-3601-44fa-83cf-357687cc2f37 61 fields · synced May 19, 2026
- EUDAMED 653b1312-2b51-417c-8d64-7d41ae527f72 61 fields · synced May 19, 2026
- EUDAMED 1d1894dc-86ec-4667-996a-ca10f8ac254c-1 61 fields · synced Jun 9, 2026
- EUDAMED 7fc53bc3-85d1-457f-94f1-9c83ea576318-1 61 fields · synced Jul 10, 2026
- EUDAMED ed3a935b-1d07-4f7c-a24f-0f2ab2243a97-2 61 fields · synced Jul 16, 2026