Identity
- Device Name
- Coated Step Drills EUDAMED
- Model / Reference
- TKDC-T8C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290111276408 EUDAMED
- Basic UDI-DI
- 72911127StepDrillsST EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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
Coated Step Drills by A.B. Dental Devices Ltd — 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 | 72911127StepDrillsST | Class IIa | Active |
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Manufacturer
- Manufacturer
- A.B. Dental Devices Ltd
- EUDAMED SRN
- IL-MF-000008766
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (1)
- EUDAMED 8031ee57-7d5b-48e7-9e53-73e7ae5c52f5 61 fields · synced Jul 11, 2026