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Orthodontic Metal Brackets
EUDAMEDClass IIa (EU MDR)
Ref Galaxy 2.0, Roth 0.022" LL2Model Roth
Identity
- Trade Name
- Orthodontic Metal Brackets EUDAMED
- Device Name
- Orthodontic Metal Brackets EUDAMED
- Model / Reference
- Roth EUDAMEDGalaxy 2.0, Roth 0.022" LL2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942665511054 EUDAMED
- Basic UDI-DI
- 697443505MR009GE 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 | 697443505MR009GE | Class IIa | Active |
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Manufacturer
- Manufacturer
- Creative Dental
- EUDAMED SRN
- CN-MF-000025975
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 5376fd6e-5268-4744-b886-173b6dc35983 61 fields · synced Jul 9, 2026
- EUDAMED 5376fd6e-5268-4744-b886-173b6dc35983-1 61 fields · synced Jun 9, 2026