Identity
- Trade Name
- ZERAMEX® MX Drill Ø3.0mm EUDAMED
- Device Name
- Surgical drills EUDAMED
- Model / Reference
- MX35633 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640161394353 EUDAMED
- Basic UDI-DI
- 764016139T3XXXXKL2ASDR2 EUDAMED
- Direct Marketing DI
- 07640161394353 EUDAMED
- EMDN Code
- L1104 BITS FOR NEUROSURGERY DRILLS, REUSABLE 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
ZERAMEX® MX Drill Ø3.0mm by CeramTec Schweiz GmbH — 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 | 764016139T3XXXXKL2ASDR2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- CeramTec Schweiz GmbH
- EUDAMED SRN
- CH-MF-000024169
- Authorised Representative
- CeramTec Dentalvertriebs GmbH DE-AR-000020220
Sources (1)
- EUDAMED 73e5ab7d-8c19-40d4-a1d8-cf5aedba9f2f 61 fields · synced Jun 18, 2026