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OrthoFlex RA - Spitze gross
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1332RA-6Model 16412
Identity
- Trade Name
- OrthoFlex RA - Spitze gross EUDAMEDEDENTA FDA UDI
- Generic Name
- Dental abrasive point, reusable FDA UDI
- Device Name
- Polierer / Arkansas EUDAMEDOrthoFlex RA FDA UDI
- Model / Reference
- 16412 EUDAMED1332RA-6 EUDAMEDFDA UDI
- Description
- OrthoFlex RA FDA UDI
Identifiers
- Primary DI / UDI-DI
- E3121332RA61 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31216412DU EUDAMED
- Unit of Use DI
- E3121332RA6101 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
OrthoFlex RA - Spitze gross 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 (2)
- EUDAMED a76b28d4-8c47-4a0d-8393-f1c7b4b69092 61 fields · synced Jul 14, 2026
- FDA UDI 263d8433-d160-4dcd-8593-ad602f09ed8e 33 fields · synced May 30, 2026