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CORE Drill
EUDAMEDClass IIa (EU MDR)
Ref CORE DrillModel CORE1/REBORN Surgical Instrument
Identity
- Trade Name
- CORE Drill EUDAMED
- Device Name
- CORE1/REBORN Surgical Instrument EUDAMED
- Model / Reference
- CORE1/REBORN Surgical Instrument EUDAMEDCORE Drill EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800023124415 EUDAMED
- Basic UDI-DI
- 88000231DntSurgicaIns2GY EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa 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
CORE Drill by Cybermed Inc. — 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 | 88000231DntSurgicaIns2GY | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cybermed Inc.,
- EUDAMED SRN
- KR-MF-000009356
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED d8f63c57-ea9a-4607-81b7-b125cdcba2f7 61 fields · synced Jul 13, 2026