Identity
- Device Name
- Coated implant drills and accessories EUDAMED
- Model / Reference
- SD4246L13C EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290119530892 EUDAMED
- Basic UDI-DI
- 729011953DDC023H EUDAMED
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Germany 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 implant drills and accessories by Carmex Precision Tools 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 | 729011953DDC023H | Class IIa | Active |
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Manufacturer
- Manufacturer
- Carmex Precision Tools Ltd.
- EUDAMED SRN
- IL-MF-000014627
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (1)
- EUDAMED d2b6c6ca-aa38-4516-9710-8e3941712b2c 61 fields · synced Jun 18, 2026