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CeraGloss RA - gelb
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 30032RA-100Model 16412Ref 30035RA-3Ref 30032RA-25Ref 30033RA-6Ref 30033RA-25Ref 30036RA-100
Identity
- Trade Name
- CeraGloss RA - gelb EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDCeraGloss RA - yellow FDA UDI
- Model / Reference
- 16412 EUDAMED30032RA-100 EUDAMED30035RA-3 EUDAMED30032RA-25 EUDAMED30033RA-6 EUDAMEDFDA UDI30033RA-25 EUDAMED30036RA-100 EUDAMED
- Description
- CeraGloss RA - yellow FDA UDI
Identifiers
- Primary DI / UDI-DI
- E31230032RA1001 EUDAMEDE31230035RA31 EUDAMEDE31230032RA251 EUDAMEDE31230033RA61 EUDAMEDFDA UDIE31230033RA251 EUDAMEDE31230036RA1001 EUDAMED
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E31230033RA6101 EUDAMEDE31230036RA100101 EUDAMEDE31230035RA3101 EUDAMEDE31230033RA25101 EUDAMEDE31230032RA100101 EUDAMEDE31230032RA25101 EUDAMED
- FDA Product Code
- EJQ FDA UDI
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
- GMDN Term
- Dental abrasive point, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.6010 FDA UDI
- Market of Registration
- Liechtenstein EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
CeraGloss RA - gelb by Edenta Etablissement — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | ++E31216412DU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (12)
- EUDAMED 22ff86fd-ae56-4922-85eb-39babaf11087 61 fields · synced Aug 4, 2026
- EUDAMED 14492408-bb7e-4a18-9536-80f3303f505e 61 fields · synced May 17, 2026
- EUDAMED d6fb1691-999f-4789-ac41-0e68d9e800c1 61 fields · synced May 17, 2026
- EUDAMED 2e9abb42-b2f9-4383-9927-555c05f693f1 61 fields · synced May 18, 2026
- EUDAMED d6a51e37-0404-4c65-a286-ab8c30044853 61 fields · synced May 18, 2026
- EUDAMED fd54a8c8-19da-40a1-a749-506619985c7d 61 fields · synced May 19, 2026
- FDA UDI 33395b93-08bd-47a0-9422-2803546772a7 33 fields · synced May 30, 2026
- EUDAMED 86783a9a-0316-4b83-a83f-6c4b2c7de23c 61 fields · synced Jul 14, 2026
- EUDAMED b834c2ca-7296-45eb-8f85-f04da1d56f3f 61 fields · synced Jul 18, 2026
- EUDAMED 4c8c2cf8-7735-46c1-85c8-dd848fe95570 61 fields · synced Jul 20, 2026
- EUDAMED 6078f529-3107-486f-bb56-5472bda79789 61 fields · synced Jul 26, 2026
- EUDAMED 4d2ff30f-84d2-4b76-b12d-b6e40202a9d5 61 fields · synced Aug 4, 2026