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Orthodontic Elastomeric Auxiliaries
EUDAMEDClass IIa (EU MDR)
Ref Orthodontic ligatures normal gem blueModel Ligature Ties
Identity
- Trade Name
- Orthodontic Elastomeric Auxiliaries EUDAMED
- Device Name
- Orthodontic Elastomeric Auxiliaries EUDAMED
- Model / Reference
- Ligature Ties EUDAMEDOrthodontic ligatures normal gem blue EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974435052955 EUDAMED
- Basic UDI-DI
- 697443505P01P8 EUDAMED
- EMDN Code
- Q010406 ORTHODONTIC LIGATURES 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 Elastomeric Auxiliaries 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 | 697443505P01P8 | 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 c04754d1-e0aa-4774-a34f-ec292325c84c 61 fields · synced Jun 19, 2026
- EUDAMED bd4840c1-6e01-4e25-a2c0-e459a898547c 61 fields · synced Jun 19, 2026