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Hymedix Intl., Inc.

United StatesFDA applicant, unverified

Devices
2

What Hymedix Intl., Inc. makes

Hymedix Intl., Inc. manufactures Hydro-S Wound Gel, a topical gel designed for wound care, and HydroSkin Wound Dressing, a sterile adhesive dressing intended for protecting and managing minor to moderate wounds.

The company’s products are classified as Class I and Unclassified (U) devices under FDA regulations, with some models supported by 510(k) clearance. The portfolio is listed in the FDA’s 510(k) database, and the manufacturer is based in the United States.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue2

Newest first, rows 1-2 of 2

  • Hydro-S Wound Gel Ref K942419

    Active Regimes: 510(k) Registry: 510(k) Class:—
  • Hydroskin Wound Dressing Ref K942815

    Active Regimes: 510(k) Registry: 510(k) Class:I

Frequently asked questions

How many devices does Hymedix Intl., Inc. have in the registry?

The registry currently lists 2 devices for Hymedix Intl., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Hymedix Intl., Inc.'s devices?

Among its 2 most recently registered devices, Hymedix Intl., Inc. has devices listed in FDA 510(k) (2 devices).

What risk classes do Hymedix Intl., Inc.'s devices fall under?

Among its 2 most recently registered devices, the classes recorded for Hymedix Intl., Inc.'s devices are Class I. Each device page shows its own class and authorisation.

What are the newest devices from Hymedix Intl., Inc. in the registry?

The most recently registered devices listed for Hymedix Intl., Inc. include HYDRO-S WOUND GEL and HYDROSKIN WOUND DRESSING.

Generated automatically from registry data and not verified by a human reviewer.