Manufacturer registered with FDA
medmix Switzerland AG
Haag, Switzerland. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 840 registrations outside the US
- Establishments
- 1Switzerland
Registered in 8 markets
Where regulators' registries name medmix Switzerland AG 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 | medmix Switzerland AG | 5 device types | — | Below |
| South Korea | MFDS | Manufacturer | medmix Switzerland AGMedmix Switzerland AG · MedMix Switzerland AG · +1 | 13 | 2012–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | medmix Switzerland AG | 8 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | medmix Switzerland AG | 7 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MEDMIX SWITZERLAND AG | 5 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MEDMIX SWITZERLAND AG | 4 | 2024–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Medmix Switzerland AG | 2 | 2025–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | medmix Switzerland AG | 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 medmix Switzerland AG 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 Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | INSTRUMENTS, DENTAL HAND | 2015 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | 2022 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | Syringe, cartridge | 2019 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | PLUGGER, ROOT CANAL, ENDODONTIC | 2019 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Micro Applicator, ZerofloX | 2019 |
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 |
|---|---|---|
| medmix Switzerland AGFDA reg. 3007497008 | Haag Sankt Gallen, Switzerland | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049141). 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.