Biodynamics Corp.
United StatesFDA applicant, unverified
- Devices
- 21
What Biodynamics Corp. makes
Biodynamics Corp. manufactures medical devices including blood processing equipment like the ADR-22 Automatic Dialyzer Reprocessor and Autotransfusion Apparatus, as well as body composition analyzers such as the BI-400 and BI-300 models. Their portfolio also includes laboratory diagnostics like the Chemstrip UG and Chemstrip L urine test strips, potassium testing devices such as the Unitest-Potassium, and centrifugal separation systems like the Universal and Basic Centrifuges. Additional offerings include the Infumix Mixing Container for intravenous solutions and the Autoclix, a sterilization device.
The company’s devices are regulated under the FDA’s 510(k) pathway, with products classified as either Class I or Class II. These devices are listed in the FDA’s 510(k) clearance registry, reflecting their compliance with U.S. medical device regulations. Biodynamics Corp. is based in the United States.
Catalogue
Search and filter all 21 devicesFrequently asked questions
How many devices does Biodynamics Corp. have in the registry?
The registry currently lists 21 devices for Biodynamics Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Biodynamics Corp.'s devices?
Among its 21 most recently registered devices, Biodynamics Corp. has devices listed in FDA 510(k) (21 devices).
What risk classes do Biodynamics Corp.'s devices fall under?
Among its 21 most recently registered devices, the classes recorded for Biodynamics Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Biodynamics Corp. in the registry?
The most recently registered devices listed for Biodynamics Corp. include AUTOTRANSFUSION APPARATUS, ADR-22 AUTOMATIC DIALYZER REPROCESSOR, BCA 1000 and INFUMIX MIXING CONTAINER.