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Dental rotary instruments
EUDAMEDClass IIa (EU MDR)
Ref 151-4133-20
by Leone S.p.a.
Identity
- Device Name
- Dental rotary instruments EUDAMED
- Model / Reference
- 151-4133-20 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08033707106401 EUDAMED
- Basic UDI-DI
- B-08033707106401 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
Dental rotary instruments by Leone S.p.a. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08033707106401 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Leone S.p.a.
- EUDAMED SRN
- IT-MF-000005986
Sources (1)
- EUDAMED bea2347d-3c74-4e0f-8f38-8d0666c69b58 61 fields · synced Jun 18, 2026