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DiaGloss RA - rosa
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1933RA-100Model 16412Ref 1934RA-25Ref 1938RA-25Ref 1939RA-25Ref 1932RA-25
Identity
- Trade Name
- DiaGloss RA - rosa EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDDiaGloss RA - pink FDA UDI
- Model / Reference
- 16412 EUDAMED1933RA-100 EUDAMEDFDA UDI1934RA-25 EUDAMED1938RA-25 EUDAMED1939RA-25 EUDAMED1932RA-25 EUDAMED
- Description
- DiaGloss RA - pink FDA UDI
Identifiers
- Catalog Number
- P1933X FDA UDI
- Primary DI / UDI-DI
- E3121933RA1001 EUDAMEDFDA UDIE3121934RA251 EUDAMEDE3121938RA251 EUDAMEDE3121939RA251 EUDAMEDE3121932RA251 EUDAMED
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E3121933RA100101 EUDAMEDE3121934RA25101 EUDAMEDE3121932RA25101 EUDAMEDE3121939RA25101 EUDAMEDE3121938RA25101 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
DiaGloss RA - rosa 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 (10)
- EUDAMED 1d4b9ab5-a68e-49f1-a827-faa5a7f6f581 61 fields · synced Sep 18, 2026
- EUDAMED 843b5316-e11d-48de-8aeb-fe743060d246 61 fields · synced May 16, 2026
- EUDAMED 6a6fa03d-ed6e-42b4-88e5-ed903a53f7c7 61 fields · synced May 17, 2026
- EUDAMED ff5159de-815c-41d8-b11c-3a556042f27e 61 fields · synced May 17, 2026
- EUDAMED e6163bc7-82b8-462f-ad7d-bc8ccfc5c780 61 fields · synced May 18, 2026
- FDA UDI 0264d916-e9af-45dd-9453-cba0021738c4 34 fields · synced May 30, 2026
- EUDAMED dae150c9-9172-45ee-97cd-0e0f8f177f42 61 fields · synced Jun 20, 2026
- EUDAMED 6fe84241-31df-4b70-88d8-2f4ea01ae827 61 fields · synced Jul 9, 2026
- EUDAMED 80da5b10-fe6b-4fb0-b774-32ba46890f29 61 fields · synced Jul 27, 2026
- EUDAMED 0813a4a7-3c45-4ab5-8eab-5daf8108698f 61 fields · synced Sep 18, 2026