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Orthodontic Ceramic Brackets
EUDAMEDClass IIa (EU MDR)
Ref Clever C, Self ligating, Roth 0.022" 345 hooksModel Roth
Identity
- Trade Name
- Orthodontic Ceramic Brackets EUDAMED
- Device Name
- Orthodontic Ceramic Brackets EUDAMED
- Model / Reference
- Roth EUDAMEDClever C, Self ligating, Roth 0.022" 345 hooks EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06942665512679 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
Category: Orthodontic tube
Orthodontic Ceramic Brackets by Creative Dental — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (1)
- EUDAMED e5a7a100-ab92-4922-9c4b-b76c35d681de 61 fields · synced Jun 5, 2026