Registered with FDA
德国吉米有限公司 GIMMI GmbH
TUTTLINGEN, Germany. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 137,110 registrations outside the US
- Establishments
- 1Germany
Registered in 13 markets
Where regulators' registries name 德国吉米有限公司 GIMMI GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Lister | 德国吉米有限公司 GIMMI GmbH | 1 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | GIMMI GMBH | 2,589 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Gimmi GmbH | 2,452 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Gimmi GmbHGIMMI GmbH | 1,461 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Gimmi GmbH | 163 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | GIMMI GMBH | 148 | 2002–2017 | Pure Global AI |
| South Korea | MFDS | Manufacturer | GIMMI GmbHGimmi · Gimmi GmbH · +2 | 84 | 1999–2022 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | GIMMI GmbH | 80 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GIMMI GmbHGIMMI GMBH · GIMMI GMbH | 71 | 2022–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GIMMI GMBH.GIMMI GMBH | 34 | 2005–2015 | Pure Global AI |
| China | NMPA | Registration holder | 德国吉米有限公司GIMMI GmbH德国吉米有限公司 GIMMI GmbH | 16 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | GIMMI GMBH | 7 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Gimmi GmbHGIMMI GmbH · Gimmi Gmbh | 5 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What 德国吉米有限公司 GIMMI GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Crown RemoverEIS · Class 1 | Dental hand instruments | Lister | — | 1989 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| GIMMI GMBHFDA reg. 9612074 | TUTTLINGEN Baden-Wurttemberg, Germany | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010570). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.