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Chirurgische Fräser HP
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref RF162.104.016Model 11341
Identity
- Trade Name
- Chirurgische Fräser HP EUDAMEDEDENTA FDA UDI
- Generic Name
- Carbide dental bur, reusable FDA UDI
- Device Name
- Chirurgie Fräser EUDAMEDSurgical cutters HP FDA UDI
- Model / Reference
- 11341 EUDAMEDRF162.104.016 EUDAMEDFDA UDI
- Description
- Surgical cutters HP FDA UDI
Identifiers
- Catalog Number
- RF162-104-016 FDA UDI
- Primary DI / UDI-DI
- E312RF1621040161 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31211341CT EUDAMED
- Unit of Use DI
- E312RF162104016101 EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- L159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMED
- GMDN Term
- Carbide dental bur, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3240 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
Chirurgische Fräser HP 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 | ++E31211341CT | 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 c7b1bcfc-91a6-4368-98c2-77e0d6202bf1 61 fields · synced Jun 18, 2026
- FDA UDI 98250de8-9738-4a14-a87d-b3ddfa3fc41b 34 fields · synced May 30, 2026