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CompGloss RA - Kelch - Dunkelgrün
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1035RA-6Model 16412Ref 1035RA-25
Identity
- Trade Name
- CompGloss RA - Kelch - Dunkelgrün EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDCompGloss RA - cup FDA UDI
- Model / Reference
- 16412 EUDAMED1035RA-6 EUDAMEDFDA UDI1035RA-25 EUDAMED
- Description
- CompGloss RA - cup FDA UDI
Identifiers
- Primary DI / UDI-DI
- E3121035RA61 EUDAMEDFDA UDIE3121035RA251 EUDAMED
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E3121035RA6101 EUDAMEDE3121035RA25101 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 - Kelch - 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 84e45a52-4f42-4c0e-a872-a3fedafad5f7 61 fields · synced Aug 3, 2026
- EUDAMED 939ff54f-efc8-426e-9f18-25aa9fb2170b 61 fields · synced May 18, 2026
- FDA UDI f96057d9-32d3-46f3-a73e-5cd54918a268 33 fields · synced May 30, 2026
- EUDAMED a64588ef-e703-4774-a164-a9df9c8a5376 61 fields · synced Aug 3, 2026