Manufacturer registered with FDA
evonos GmbH & Co. KG
Tuttlingen, Germany. Lists 3 dental device types with FDA across 2 registered establishments.
- Device types listed
- 3
- Brands and models
- 0
- 510(k) clearances
- 0as applicant
- Markets registered in
- 13307 registrations outside the US
- Establishments
- 2Germany
Registered in 13 markets
Where regulators' registries name evonos GmbH & Co. KG 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 | evonos GmbH & Co. KG | 3 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | evonos GmbH & Co. KG | 96 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | EVONOS GMBH & CO. KG | 92 | 2009–2025 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | EVONOS GMBH & CO. KGEVONOS GMBH & CO.KG | 29 | 2013–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | evonos GmbH & Co. KGEVONOS GmbH & Co.KG · evonos GmbH & Co.KG | 24 | 2007–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | EVONOS GmbH & Co. KG | 16 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Evonos GmbH & Co.KGEvonos GmbH & Co. KG · evonos GmbH & Co. KG | 13 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | EVONOS GMBH & CO. KG | 12 | 2015–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | EVONOS GmBh &Co. KGEVONOS GmbH &Co. KG | 10 | — | Pure Global AI |
| Colombia | INVIMA | Registration holder | EVONOS GMBH & CO. KG | 7 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | evonos GmbH & Co. KG | 4 | 2025–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Evonos GmbH & Co KG | 3 | 2016–2023 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | EVONOS GmbH & Co. KG | 1 | 2025–2025 | 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 evonos GmbH & Co. KG 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 Headlight LightEBA · Class 1 | Dental operating lights | Maker | — | 2015 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | — | 1984 |
| Periodontic HoeEMQ · Class 1 | Dental hand instruments | Maker | — | 2018 |
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 |
|---|---|---|
| EVONOS GMBH & CO. KGFDA reg. 3010726901 | Tuttlingen Baden-Wurttemberg, Germany | Manufacturer |
| FRITZ HUBER GmbH & Co. KGFDA reg. 9611814 | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer |
Other names on FDA records
FRITZ HUBER GmbH & Co. KG
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048205, 8010248). 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.