Identity
- Trade Name
- SICwhite Prosthetic Tray EUDAMED
- Device Name
- Instrument trays EUDAMED
- Model / Reference
- 970985 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640161396203 EUDAMED
- Basic UDI-DI
- 764016139XX488YYK01SUU7 EUDAMED
- EMDN Code
- V0402 CLINICAL USE TRAYS AND BOWLS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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 Prosthetic Tray by CeramTec Schweiz GmbH — Class I — 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 | 764016139XX488YYK01SUU7 | Class I | 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 0f5c0432-8d60-4547-a50e-90e009a19f49 61 fields · synced Jun 19, 2026