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CompGloss RA - Kelch - Hellgrün
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1135RA-6Model 16412Ref 1135RA-25
Identity
- Trade Name
- CompGloss RA - Kelch - Hellgrün EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDCompGloss RA - cup FDA UDI
- Model / Reference
- 16412 EUDAMED1135RA-6 EUDAMEDFDA UDI1135RA-25 EUDAMED
- Description
- CompGloss RA - cup FDA UDI
Identifiers
- Primary DI / UDI-DI
- E3121135RA61 EUDAMEDFDA UDIE3121135RA251 EUDAMED
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E3121135RA6101 EUDAMEDE3121135RA25101 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 - Hellgrün 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 941dfeab-7fe9-41b5-bf18-a4a48df17fbd 61 fields · synced Jul 18, 2026
- EUDAMED ab6fe5ac-3af5-4bbd-9ee2-2fa87f2945b7 61 fields · synced May 18, 2026
- FDA UDI b57d0f48-7d6b-4ccc-8356-a58ce8f01cb4 33 fields · synced May 30, 2026
- EUDAMED 0347d123-8e08-46a8-acea-b7588ed1ed72 61 fields · synced Jul 14, 2026