Hans J. Brouwers & Assoc.
Country not established
- Devices
- 2
What Hans J. Brouwers & Assoc. makes
Hans J. Brouwers & Assoc. manufactures in-vitro diagnostic devices, including a cholesterol test system for measuring blood cholesterol levels and a plasma extraction system for separating plasma from whole blood samples.
The company’s portfolio includes Class I and Class II devices, with some products authorised via the FDA’s 510(k) pathway. These devices are listed under US regulatory requirements, and the company operates from the United States.
Catalogue
Cholesterol Test System Ref K850390
Regimes: 510(k) Registry: 510(k)Plasma Extraction System Ref K850391
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hans J. Brouwers & Assoc. have in the registry?
The registry currently lists 2 devices for Hans J. Brouwers & Assoc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hans J. Brouwers & Assoc.'s devices?
Among its 2 most recently registered devices, Hans J. Brouwers & Assoc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Hans J. Brouwers & Assoc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hans J. Brouwers & Assoc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hans J. Brouwers & Assoc. in the registry?
The most recently registered devices listed for Hans J. Brouwers & Assoc. include CHOLESTEROL TEST SYSTEM and PLASMA EXTRACTION SYSTEM.