Identity
- Trade Name
- HM Fräser EUDAMEDEDENTA FDA UDI
- Generic Name
- Carbide dental bur, reusable FDA UDI
- Device Name
- Podologie Schleifer EUDAMEDTC Cutter FDA UDI
- Model / Reference
- 17761 EUDAMED6210.040HP EUDAMEDFDA UDI
- Description
- TC Cutter FDA UDI
Identifiers
- Catalog Number
- UC351E-040 FDA UDI
- Primary DI / UDI-DI
- E3126210040HP1 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E31217761EX EUDAMED
- FDA Product Code
- EJL FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS 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
HM Fräser 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 | ++E31217761EX | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Edenta Etablissement
- EUDAMED SRN
- LI-MF-000011937
Sources (2)
- EUDAMED c60e28f0-d49b-4ecb-8dfc-75fee21182ef 61 fields · synced Aug 1, 2026
- FDA UDI 48e3cb0c-a2dd-4118-a79f-1da1040f3461 34 fields · synced May 30, 2026