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Orthodontic Ceramic Brackets
EUDAMEDClass IIa (EU MDR)
Ref Standard bracket Roth.022",Hook on Tooth#3Model Roth
Identity
- Trade Name
- Orthodontic Ceramic Brackets EUDAMED
- Device Name
- Orthodontic Ceramic Brackets EUDAMED
- Model / Reference
- Roth EUDAMEDStandard bracket Roth.022",Hook on Tooth#3 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974435052351 EUDAMED
- Basic UDI-DI
- 697443505CR010CH 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
Yes
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 Ceramic 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 | 697443505CR010CH | 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 619c3fe9-d2f1-4dc6-bdb7-72c3a10a2f26 61 fields · synced Jun 18, 2026
- EUDAMED 619c3fe9-d2f1-4dc6-bdb7-72c3a10a2f26-1 61 fields · synced Jun 10, 2026