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Surgical instruments
EUDAMEDClass IIa (EU MDR)
Ref DR 8105Model Surgical instruments
Identity
- Device Name
- Surgical instruments EUDAMED
- Model / Reference
- Surgical instruments EUDAMEDDR 8105 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08059571001246 EUDAMED
- Basic UDI-DI
- 805957100STRUMENTARIO9V EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS 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
Surgical instruments by ZIACOM ITS S.r.l. — 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 | 805957100STRUMENTARIO9V | Class IIa | Active |
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Manufacturer
- Manufacturer
- ZIACOM ITS S.r.l.
- EUDAMED SRN
- IT-MF-000028897
Sources (1)
- EUDAMED 37340822-80dd-4c27-bd45-0c9c74a344f6 61 fields · synced Jun 11, 2026