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Alphaflex RA - braun
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 0033RA-25Model 16412Ref 0032RA-25Ref 0036RA-100
Identity
- Trade Name
- Alphaflex RA - braun EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDAlphaflex RA - brown FDA UDI
- Model / Reference
- 16412 EUDAMED0033RA-25 EUDAMED0032RA-25 EUDAMED0036RA-100 EUDAMEDFDA UDI
- Description
- Alphaflex RA - brown FDA UDI
Identifiers
- Primary DI / UDI-DI
- E3120033RA251 EUDAMEDE3120032RA251 EUDAMEDE3120036RA1001 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E3120036RA100101 EUDAMEDE3120032RA25101 EUDAMEDE3120033RA25101 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
Alphaflex RA - braun 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 (6)
- EUDAMED 644bb3b5-f2dc-44e6-89e1-0d8746593002 61 fields · synced Jul 30, 2026
- EUDAMED ae9af148-aa5f-4875-b507-f3ac6a2e31b0 61 fields · synced May 16, 2026
- EUDAMED 48dea962-cefb-4d7b-8a44-c8ca4f262ac4 61 fields · synced May 18, 2026
- FDA UDI 8e6ed4f3-a336-4573-9857-8747e141455f 33 fields · synced May 30, 2026
- EUDAMED a0cda00e-6e2f-4749-a980-9b1ff9eff824 61 fields · synced Jul 14, 2026
- EUDAMED d2b7eb81-99f4-43c0-b8b0-f2e2a468c889 61 fields · synced Jul 30, 2026