Braun GmbH
Country not established FDA
- Devices
- 8
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Braun GmbH makes
Braun GmbH manufactures infrared thermometers for professional and home use, including models like the Thermoscan Pro 4000 Series (for clinical environments) and Thermoscan IRT 2000 Series (for personal use). Their portfolio also includes precision sensors, such as the BP 2000 and BP 2590 Series, designed for temperature monitoring. Additionally, the company produces electric toothbrushes under the Oral-B brand, including the Sonic Complete and ProfessionalCare Series.
The company’s devices are classified under FDA categories Class I and Class II, with relevant products listed via the 510(k) pathway. These products are intended for use in the United States, adhering to regulatory requirements for medical and dental devices. The manufacturer is based in the US.
Catalogue
- 510(k) 510(k)
Braun Precision Sensor, Model Bp 2000 Series Ref K003732
510(k) 510(k)- 510(k) 510(k)
Braun Thermoscan PRO3000 Infared Thermometer Ref K992468
510(k) 510(k)Oral-B Sonic Complete Ref K061351
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
Braun Precision Sensor Pro, Model Bp 2590 Ref K012035
510(k) 510(k)
FDA establishments
- Braun GmbH KRONBERG Hesse · DE FEI 1000227535
Frequently asked questions
How many devices does Braun GmbH have in the registry?
The registry currently lists 8 devices for Braun GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Braun GmbH's devices?
Among its 8 most recently registered devices, Braun GmbH has devices listed in FDA 510(k) (8 devices).
What risk classes do Braun GmbH's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Braun GmbH's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Braun GmbH in the registry?
The most recently registered devices listed for Braun GmbH include BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT), BRAUN PRECISION SENSOR, MODEL BP 2000 SERIES, BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520 and BRAUN THERMOSCAN PRO3000 INFARED THERMOMETER.
Which FDA establishments are linked to Braun GmbH?
1 FDA establishment is linked to Braun GmbH in the registry; they are listed on the company page.