Medirex, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Medirex, Inc. makes
Medirex, Inc. manufactures endoscopic imaging systems, including the DIGISCOPE RX-2 and its 9-option variant, which are designed for internal medical examinations. The company also produces the IPU RX-2, a related imaging unit, and the TRIPTER-X1 series of shockwave lithotripters, which are used for breaking kidney stones via extracorporeal shockwave therapy.
These devices are classified as Class II under FDA regulations and are authorised through 510(k) clearances and PMA submissions. The company’s products are listed in the U.S. regulatory system, and Medirex, Inc. is based in the United States.
Catalogue
Digiscope Rx-2 Ref K960198
Regimes: 510(k) Registry: 510(k)Ipu Rx-2 Ref K964327
Regimes: 510(k) Registry: 510(k)Digiscope Rx-2 (9 Option) Ref K965013
Regimes: 510(k) Registry: 510(k)Tripter-X1 Series Shockwave Lithotripters Ref P920034
Regimes: PMA Registry: PMA
Frequently asked questions
How many devices does Medirex, Inc. have in the registry?
The registry currently lists 4 devices for Medirex, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medirex, Inc.'s devices?
Among its 4 most recently registered devices, Medirex, Inc. has devices listed in FDA 510(k) (3 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Medirex, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Medirex, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medirex, Inc. in the registry?
The most recently registered devices listed for Medirex, Inc. include DIGISCOPE RX-2, IPU RX-2, DIGISCOPE RX-2 (9 OPTION) and TRIPTER-X1 SERIES SHOCKWAVE LITHOTRIPTERS.