Manufacturer registered with FDA
REDA Instrumente GmbH
TUTTLINGEN, Germany. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 128,149 registrations outside the US
- Establishments
- 1Germany
Registered in 12 markets
Where regulators' registries name REDA Instrumente 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 | Manufacturer | REDA Instrumente GmbH | 4 device types | — | Below |
| Thailand | Thai FDA | Manufacturer | REDA INSTRUMENTE GMBH | 7,265 | — | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | REDA Instrumente GmbH | 282 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | REDA Instrumente GmbH | 185 | 2022–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | REDA Instrumente GmbHREDA Instrumente GMBH · Reda Instrumente Gmbh · +2 | 167 | 1998–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | REDA Instrumente GmbH | 84 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | REDA Instrumente GmbH | 77 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | REDA INSTRUMENTE GMBH | 34 | 2003–2025 | Pure Global AI |
| Colombia | INVIMA | Registration holder | REDA INSTRUMENTE GMBH | 25 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | REDA INSTRUMENTE GmbHREDA INSTRUMENTE GMBH | 15 | 2022–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | REDA INSTRUMENTE GMBH | 10 | 2005–2021 | Pure Global AI |
| Israel | AMAR | Manufacturer | REDA INSTRUMENTEREDA Instrumente GmbH · REDA instrumente 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 REDA Instrumente 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 |
|---|---|---|---|---|
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | — | 1991 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | — | 1991 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | — | 2004 |
| Surgical Rongeur ForcepsEMH · 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 |
|---|---|---|
| REDA INSTRUMENTE GMBHFDA reg. 8043496 | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9001990). 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.