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CompGloss RA - kleine Spitze - Dunkelgrün
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1033RA-6Model 16412Ref 1033RA-25
Identity
- Trade Name
- CompGloss RA - kleine Spitze - Dunkelgrün EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDCompGloss RA - small point FDA UDI
- Model / Reference
- 16412 EUDAMED1033RA-6 EUDAMEDFDA UDI1033RA-25 EUDAMED
- Description
- CompGloss RA - small point FDA UDI
Identifiers
- Primary DI / UDI-DI
- E3121033RA61 EUDAMEDFDA UDIE3121033RA251 EUDAMED
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E3121033RA6101 EUDAMEDE3121033RA25101 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
CompGloss RA - kleine Spitze - Dunkelgrün 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 6dbc391f-3c8e-4782-9576-993ccc673cbd 61 fields · synced Jul 24, 2026
- EUDAMED f0ece4ba-d571-4250-a6fa-c5131544581e 61 fields · synced May 17, 2026
- FDA UDI aaceee0b-7d9b-47de-abe1-af2b3a17c9e1 33 fields · synced May 29, 2026
- EUDAMED cf082b82-e42b-4738-8b1a-50bbc8cc034f 61 fields · synced Jul 24, 2026