CeramTec Schweiz GmbH
CH-MF-000024169 · Switzerland · Spreitenbach
CeramTec Schweiz GmbH is registered in the European database on medical devices as a manufacturer, with 189 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 189 |
|---|
Among these devices, 105 are declared reusable.
Authorised representative in the Union: CeramTec Dentalvertriebs GmbH.
Devices declared under this manufacturer
- CERALOG® PL Implant removal driver L 23.0 mm
- NobelPearl™ Rescue Driver Inter-X NP/RP/WP
- NobelPearl™ Tapered Drill NP 3.5x12mm
- NobelPearl™ Tapered Drill WP 5.5x8mm
- SICwhite Screwdriver, angle piece, 19mm
- SICwhite Transfer Abutment SB, reposition, short
- ZERAMEX® MX Profil Drill SMALL
- ZERAMEX® SB Digital Implant Replica
- ZERAMEX® SB Transfer Closed Tray, long
- ZERAMEX® WB Transfer Open Tray
- ZERAMEX® XT Drill Stop, for REGULAR Drill
- ZERAMEX® XT Drill Stop, for SMALL Drill
Showing 12 of 189 declared devices.
Catalogue references include 300735, 970961, HP5330.0002, R98120, SB35513, WB37510.
European nomenclature codes declared: Q0199, Q010207, Q010280, L159099, L0180, V0402.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | CeramTec Schweiz GmbH (CH) · FDA 3008388248 |
| Devices in EUDAMED | 189 |
| Country of registration | Switzerland |
Device-level evidence
| Devices with a numeric GTIN | 189 |
|---|---|
| Found in the U.S. device database | 123 |
| Share | 65.1 % |
Canadian market access
| Health Canada licence listing | Not found in the Canadian register |
|---|
⚠️ Canada lists no Class I devices at all — what that excludes.
North American profile: United States only. CeramTec Schweiz GmbH is registered in the United States but was not found in the Canadian register.