Identity
- Trade Name
- DRILLBO EUDAMED
- Device Name
- Bohrerschale EUDAMED
- Model / Reference
- DRILLBO EUDAMED
Identifiers
- Primary DI / UDI-DI
- G375DRILLBO EUDAMED
- Basic UDI-DI
- ++G375DRILLBO4D EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Latvia 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
Drillbo by Immane Corporation — Class I — 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 | ++G375DRILLBO4D | Class I | Active |
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Manufacturer
- Manufacturer
- Immane Corporation
- EUDAMED SRN
- PK-MF-000035233
- Authorised Representative
- CS Active LV-AR-000011602
Sources (1)
- EUDAMED 40682786-1e99-4c7d-80e4-a78467a42f8c 61 fields · synced Jul 8, 2026