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CeraGloss RA - Lamelle - gelb
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 30039RA-100Model 16412Ref 30039RA-6
Identity
- Trade Name
- CeraGloss RA - Lamelle - gelb EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDCeraGloss RA - Lamella - yellow FDA UDI
- Model / Reference
- 16412 EUDAMED30039RA-100 EUDAMED30039RA-6 EUDAMEDFDA UDI
- Description
- CeraGloss RA - Lamella - yellow FDA UDI
Identifiers
- Catalog Number
- P30039RA-6 FDA UDI
- Primary DI / UDI-DI
- E31230039RA1001 EUDAMEDE31230039RA61 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E31230039RA6101 EUDAMEDE31230039RA100101 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 - Lamelle - 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 (4)
- EUDAMED 6fffcc90-9474-4a2a-b02d-9bbaf1be779f 61 fields · synced Jul 11, 2026
- EUDAMED a3e8090d-8216-4579-9025-0fe6309e70d4 61 fields · synced May 19, 2026
- FDA UDI a18a6280-7df4-49f9-840a-16d7e1f70eb7 34 fields · synced May 30, 2026
- EUDAMED 13b013f0-fc5c-4ccb-abff-6ec6718cd7e5 61 fields · synced Jul 11, 2026