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CeraGloss RA - blau
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 3036RA-100Model 16412Ref 3033RA-25Ref 3035RA-25Ref 3033RA-3Ref 3035RA-6Ref 3032RA-25
Identity
- Trade Name
- CeraGloss RA - blau EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDCeraGloss RA - blue FDA UDI
- Model / Reference
- 16412 EUDAMED3036RA-100 EUDAMED3033RA-25 EUDAMED3035RA-25 EUDAMED3033RA-3 EUDAMED3035RA-6 EUDAMEDFDA UDI3032RA-25 EUDAMED
- Description
- CeraGloss RA - blue FDA UDI
Identifiers
- Primary DI / UDI-DI
- E3123036RA1001 EUDAMEDE3123033RA251 EUDAMEDE3123035RA251 EUDAMEDE3123033RA31 EUDAMEDE3123035RA61 EUDAMEDFDA UDIE3123032RA251 EUDAMED
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E3123035RA6101 EUDAMEDE3123035RA25101 EUDAMEDE3123032RA25101 EUDAMEDE3123033RA25101 EUDAMEDE3123033RA3101 EUDAMEDE3123036RA100101 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 - blau 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 ba904613-0058-4afc-b45f-dd5e7bf3e510 61 fields · synced Jul 25, 2026
- EUDAMED a6039bb2-5178-44a3-8a6c-bc2c263bce7d 61 fields · synced May 17, 2026
- EUDAMED a6757309-f7b4-4cc7-b8a9-74a12d10e720 61 fields · synced May 17, 2026
- EUDAMED a772f5a9-fffc-413c-a4c4-c3cde62395f4 61 fields · synced May 18, 2026
- EUDAMED 501f1767-e827-4f77-b3e5-2ba1ff85591b 61 fields · synced May 18, 2026
- EUDAMED ac1e8d39-04e8-4ef5-89e1-ea0bb6676ec0 61 fields · synced May 19, 2026
- FDA UDI b3a3bf6d-8306-4cd7-85ca-b596700b7003 33 fields · synced May 30, 2026
- EUDAMED 431761d4-8c7a-45f6-9ca3-3706a3f44b90 61 fields · synced Jun 20, 2026
- EUDAMED 306d5c0b-b594-4017-ab42-6457500de085 61 fields · synced Jul 9, 2026
- EUDAMED dd66b3ac-41be-4dcd-bbbb-5441e86f0832 61 fields · synced Jul 10, 2026
- EUDAMED d6098f89-9898-407c-9881-1bb937e540be 61 fields · synced Jul 10, 2026
- EUDAMED 12ed065e-dd66-41e2-8e96-43b6b6489223 61 fields · synced Jul 25, 2026