Identity
- Trade Name
- Dríva™ Gold Series Drills EUDAMED
- Device Name
- Sterile powered surgically invasive instrument EUDAMED
- Model / Reference
- OP4G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00844868044314 EUDAMED
- Basic UDI-DI
- 844868AFJ2 EUDAMED
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Dríva™ Gold Series Drills by ZimVie US Corp LLC — 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 | 844868AFJ2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- ZimVie US Corp LLC
- EUDAMED SRN
- US-MF-000048255
- Authorised Representative
- ZimVie Spain S.L.U. ES-AR-000000983
Sources (1)
- EUDAMED d15fe02c-aef0-4bea-932b-40d794f2b10a 61 fields · synced Jul 19, 2026