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Orthodontic Elastomeric Auxiliaries
EUDAMEDClass IIa (EU MDR)
Ref Elastomeric Intra-oral Elastics 5/16Model Ligature Ties
Identity
- Trade Name
- Orthodontic Elastomeric Auxiliaries EUDAMED
- Device Name
- Orthodontic Elastomeric Auxiliaries EUDAMED
- Model / Reference
- Ligature Ties EUDAMEDElastomeric Intra-oral Elastics 5/16 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06974435050623 EUDAMED
- Basic UDI-DI
- 697443505P01P8 EUDAMED
- EMDN Code
- Q010404 ORTHODONTIC ELASTICS, CHAINS AND SPRINGS 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
Yes
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 0a11bb8b-cc9a-41ae-b625-d2c393dfea78 61 fields · synced Jun 18, 2026
- EUDAMED 32c80eff-e3ae-47ae-9139-b9dc1d4acfb9 61 fields · synced Jun 18, 2026