Polymedica Industries, Inc.
United StatesFDA applicant, unverified
- Devices
- 16
What Polymedica Industries, Inc. makes
Polymedica Industries, Inc. manufactures medical devices including digital and universal thermometers for temperature monitoring, such as the BASIS and MEDIAID models. Their portfolio also includes a range of wound dressings—including pigmented, foam, gel, and collodion-based options like SPYROFLEX, MITRAFLEX, and SPYROFOAM—as well as adhesive wound dressings like the MITRAFLEX WET-STICK. Skin protectors, such as the SPYROFLEX line, are designed to prevent breakdown in at-risk areas.
The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with several products listed via the 510(k) pathway. These products are intended for use in the United States, where regulatory compliance is governed by the FDA. The manufacturer is based in the US.
Catalogue
Search and filter all 16 devicesFrequently asked questions
How many devices does Polymedica Industries, Inc. have in the registry?
The registry currently lists 16 devices for Polymedica Industries, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Polymedica Industries, Inc.'s devices?
Among its 16 most recently registered devices, Polymedica Industries, Inc. has devices listed in FDA 510(k) (16 devices).
What risk classes do Polymedica Industries, Inc.'s devices fall under?
Among its 16 most recently registered devices, the classes recorded for Polymedica Industries, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Polymedica Industries, Inc. in the registry?
The most recently registered devices listed for Polymedica Industries, Inc. include MEDIAID UNIVERSAL THERMOMETER, SPYROFLEX SKIN PROTECTOR, BASIS FLEXIBLE TIP DIGITAL THERMOMETER and MITRAFLEX PIGMENTED WOUND DRESSING.