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Monlycke Health Care

Country not established

Devices
1

What Monlycke Health Care makes

Monlycke Health Care produces the MEPILEX AG dressing, a type of advanced wound care product designed for managing acute and chronic wounds, including pressure ulcers and diabetic foot ulcers. This hydrocolloid-based dressing is intended to create a moist wound environment to support healing while protecting against bacterial contamination.

The MEPILEX AG dressing is classified as a Class II device under FDA regulations and has been authorised through the 510(k) clearance process. The company is based in the United States, and its products are listed in the FDA’s 510(k) registry.

AI-generated from registry data, 20 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1

Newest first, rows 1-1 of 1

  • Mepilex AG Dressing Ref K071354

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

Frequently asked questions

How many devices does Monlycke Health Care have in the registry?

The registry currently lists 1 device for Monlycke Health Care. Devices recorded under merged duplicate company entries are counted once.

Which registries list Monlycke Health Care's devices?

Among its 1 most recently registered device, Monlycke Health Care has devices listed in FDA 510(k) (1 device).

What are the newest devices from Monlycke Health Care in the registry?

The most recently registered devices listed for Monlycke Health Care include MEPILEX AG DRESSING.

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