Manufacturer registered with FDA
Geister Medizintechn
TUTTLINGEN, Germany. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 166,702 registrations outside the US
- Establishments
- 1Germany
Registered in 16 markets
Where regulators' registries name Geister Medizintechn as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Geister Medizintechn | 2 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | GEISTER MEDIZINTECHNIK GMBHGeister Medizintechnik GmbH | 6,038 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Geister Medizintechnik GmbHGEISTER Medizintechnik GmbH · GEISTER Medizintechnik Gmbh · +2 | 298 | 2001–2021 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Geister Medizintechnik GmbH | 98 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | GEISTER MEDIZINTECHNIK GMBH | 71 | 2008–2008 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Geister Medizintechnik GmbH | 62 | 2025–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Geister Medizintechnik GmbH | 31 | 2004–2024 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Geister Medizintechnik GmbH | 23 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Geister medizintechnik GmbhGEISTER MEDIZINTECHNIK GMBH | 21 | 2010–2023 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | GEISTER MEDIZINTECHNIK GmbH | 18 | 2022–2022 | Pure Global AI |
| Colombia | INVIMA | Registration holder | GEISTER MEDIZINTECHNIK GMBH | 16 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Geister Medizintechnik GmbH | 11 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GEISTER MEDIZINTECHNIK GMBH | 8 | 2005–2019 | Pure Global AI |
| Israel | AMAR | Manufacturer | Geister Medizintechnik GmbH | 5 | — | Pure Global AI |
| China | NMPA | Registration holder | 盖斯特医疗技术有限公司Geister Medizintechnik GmbH | 1 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Geister Medizintechnik GmbH | 1 | — | 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 Geister Medizintechn currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | — | 1997 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | — | 1997 |
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 |
|---|---|---|
| GEISTER MEDIZINTECHNIK GMBHFDA reg. 8010697 | TUTTLINGEN Baden-Wurttemberg, Germany | Manufacturer, Repacker / relabeler |
Other names on FDA records
Geister Medizintechnik GmbH
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010697). 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.