CathRx, Ltd.
Active in EUDAMEDAustraliafrom SRN EUDAMED FDA SRN AU-MF-000002757
- Devices
- 11
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What CathRx, Ltd. makes
CathRx, Ltd. manufactures steerable and fixed-loop electrophysiology catheters designed for cardiac mapping and ablation procedures. These include single-loop and variable-loop catheters, as well as loop configurations with steerable tips to improve precision in treating arrhythmias.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.
Catalogue
Search and filter all 11 devicesCompany details
- EUDAMED SRN
- AU-MF-000002757
- EUDAMED status
- Active
- EUDAMED registered name
- CathRx Ltd
- Registered address
- Unit 8/ 2-8, South Street, 2116, Rydalmere, Australia
- Website
- www.cathrx.com
- [email protected]
- PRRC contact
- Jianhe Chen
FDA establishments
- Cathrx Rydalmere New South Wales · AU FEI 3014368660
Frequently asked questions
How many devices does CathRx, Ltd. have in the registry?
The registry currently lists 11 devices for CathRx, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list CathRx, Ltd.'s devices?
Among its 11 most recently registered devices, CathRx, Ltd. has devices listed in EUDAMED (11 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do CathRx, Ltd.'s devices fall under?
Among its 11 most recently registered devices, the classes recorded for CathRx, Ltd.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from CathRx, Ltd. in the registry?
The most recently registered devices listed for CathRx, Ltd. include Khelix Diagnostic Extension Cable 10pin, Khelix Duodecapolar Variable Loop Steerable Electrophysiology Catheter, Khelix Quadpolar Fixed Electrophysiology Catheter and Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter.
Which FDA establishments are linked to CathRx, Ltd.?
1 FDA establishment is linked to CathRx, Ltd. in the registry; they are listed on the company page.