Identity
- Trade Name
- SICwhite Drill WB 5.5x8mm EUDAMED
- Device Name
- Surgical drills EUDAMED
- Model / Reference
- 970925 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640161396036 EUDAMED
- Basic UDI-DI
- 764016139T3XXXXKL2ASDR2 EUDAMED
- Direct Marketing DI
- 07640161396036 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
SICwhite Drill WB 5.5x8mm 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 d1e80c7d-59f8-4f63-9dea-6a8bdad2495a 61 fields · synced Jul 11, 2026