Sorex Medical
Country not established
- Devices
- 9
What Sorex Medical makes
Sorex Medical manufactures medical devices for infection control, wound care, and procedural support, including air filtration systems like the PLUME MASTER and SOREX SAFE-AIR, as well as wound management trays (EDLICH WOUND MANAGEMENT TRAY) and procedural trays (MEDICAL PROCEDURE TRAY). The company also produces tracheostomy care products (TRACH-EZE) and kits for peripheral intravenous catheter insertion and exchange (PICC INSERTION KIT/P.I.C. and PICC EXCHANGE KIT/P.E.K). Additional offerings include a PICC line stabilization device (PICC-FIX) and a fog-reducing system (FOGLESS). The GRAFT GUARD is designed for surgical applications.
Sorex Medical’s devices are classified under FDA categories Class I and Class II, with submissions recorded in the FDA’s 510(k) registry. The company is based in the United States, and its products are subject to U.S. regulatory requirements for medical devices.
Catalogue
Plume Master Ref K913036
510(k) 510(k)Sorex Safe-Air Ref K911150
510(k) 510(k)Graft Guard Ref K885136
510(k) 510(k)Picc-Fix Ref K911070
510(k) 510(k)Fogless Ref K923843
510(k) 510(k)Edlich Wound Management Tray Ref K905572
510(k) 510(k)Medical Procedure Tray Ref K902410
510(k) 510(k)Trach-Eze Ref K903740
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does Sorex Medical have in the registry?
The registry currently lists 9 devices for Sorex Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sorex Medical's devices?
Among its 9 most recently registered devices, Sorex Medical has devices listed in FDA 510(k) (9 devices).
What risk classes do Sorex Medical's devices fall under?
Among its 9 most recently registered devices, the classes recorded for Sorex Medical's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sorex Medical in the registry?
The most recently registered devices listed for Sorex Medical include PLUME MASTER, SOREX SAFE-AIR, GRAFT GUARD and PICC-FIX.