Manufacturer registered with FDA
Thermo Fisher Scientific
Waltham, MA, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 172,721 registrations outside the US
- Establishments
- 1United States
Registered in 17 markets
Where regulators' registries name Thermo Fisher Scientific 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 | Thermo Fisher Scientific | 1 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Microgenics Corporation | 572 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | MICROGENICS CORPORATION | 484 | 1999–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Microgenics Corporation | 419 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | THERMO FISHER SCIENTIFICMICROGENICS CORPORATION · MICROGENICS GMBH · +1 | 365 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | MICROGENICS CORPORATIONTHERMO FISHER SCIENTIFIC INC. · THERMO FISHER SCIENTIFIC. | 216 | 2005–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Microgenics Corporation | 159 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Microgenics CorporationMicrogenics · Microgenics Corp. · +1 | 131 | 2012–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MICROGENICS CORPORATIONTHERMO FISHER SCIENTIFIC · THERMO FISHER SCIENTIFIC LLC · +1 | 99 | 2004–2025 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Microgenics Corporation | 79 | 2022–2026 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Microgenics CorporationMicrogenics GmbH | 76 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MICROGENICS CORP.MICROGENICS CORPORATION | 40 | 2013–2025 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Microgenics Corporation | 29 | 2024–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | Microgenics CorporationThermo Fisher Scientific | 24 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Microgenics Corporation | 18 | 2011–2023 | Pure Global AI |
| China | NMPA | Registration holder | 微基因公司Microgenics Corporation | 6 | — | Pure Global AI |
| Thailand | Thai FDA | Manufacturer | Microgenics Corporation | 4 | — | 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 Thermo Fisher Scientific currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | CEDIA Phenytoin II Assay | 2008 |
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 |
|---|---|---|
| Microgenics CorporationFDA reg. 3010939897 | Fremont, CA, United States | Manufacturer |
Other names on FDA records
Microgenics Corporation
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2517925). 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.