Bio Medicus, Inc.
United StatesFDA applicant, unverified
- Devices
- 15
What Bio Medicus, Inc. makes
Bio Medicus, Inc. manufactures medical devices for cardiovascular support, including extracorporeal blood pumps (e.g., the BIO PUMP models BP-50, BP-80, BP-90), cardiopulmonary cannula tubing and introducers, and portable bypass systems (e.g., the PBS Model 1000). The company also produces temperature-controlled solutions like the BIO-CAL 370 heater/cooler and specialized transport tubes, such as the urine culture stabilization tube. Additional offerings include the BIO PACK Model 200 and BIO-MEDICUS BIO CONSOLE models for monitoring and control in clinical settings.
The company’s devices are classified under FDA regulations as Class I or Class II, with relevant submissions recorded in the FDA’s 510(k) registry. These products are intended for use in the United States, where they must comply with U.S. medical device regulations. No other regulatory listings or jurisdictions are specified.
Catalogue
Search and filter all 15 devicesFrequently asked questions
How many devices does Bio Medicus, Inc. have in the registry?
The registry currently lists 15 devices for Bio Medicus, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bio Medicus, Inc.'s devices?
Among its 15 most recently registered devices, Bio Medicus, Inc. has devices listed in FDA 510(k) (15 devices).
What risk classes do Bio Medicus, Inc.'s devices fall under?
Among its 15 most recently registered devices, the classes recorded for Bio Medicus, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bio Medicus, Inc. in the registry?
The most recently registered devices listed for Bio Medicus, Inc. include BIO MEDICUS BIO PUMP MODEL BP-80, BIO-CAL 370 HEATER/COOLER, URINE CULTUR STABILIZATION TRANSPORT TUBE and CARDIOPULMONARY CANNULA TUBING.