Identity
- Trade Name
- Diamond Bur EUDAMED
- Device Name
- Rotary Bur EUDAMED
- Model / Reference
- 450857-JK5 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055165016108 EUDAMED
- Basic UDI-DI
- 80515118720000085R EUDAMED
- Unit of Use DI
- 08055165027456 EUDAMED
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
Diamond Bur by Kerr Italia Srl — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 80515118720000085R | Class IIa | Active |
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Manufacturer
- Manufacturer
- Kerr Italia Srl
- EUDAMED SRN
- IT-MF-000007768
Sources (1)
- EUDAMED a6781c84-911e-4527-9a7d-f827793acb46 61 fields · synced Aug 4, 2026