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SKINTACT

by Leonhard Lang GmbH 2 variants

510(k) K092291

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K092291↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK092291 Date21 Aug 2009ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Full name
Skintact and Various Other Tradenames
510(k) Number
FDA Product Code
DRX
Device Class
Class II
Regulation
21 CFR Part 870.2360
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

SKINTACT is a Dressing, Occlusive (per FDA nomenclature), designed to create a moist wound environment to promote healing. It is a sterile, adhesive, hydrocolloid-based dressing intended for use on partial- and full-thickness wounds, including pressure ulcers, venous ulcers, and diabetic foot ulcers.

The device is supplied as a single-use, sterile product and is intended for use in clinical settings such as hospitals, outpatient clinics, and home care. It adheres directly to the wound bed and is available in various sizes to accommodate different wound dimensions. Authorised under FDA 510K and MDR, SKINTACT complies with regulatory standards for occlusive dressings and is classified under product code DRX for wound care applications.

Other devices from Leonhard Lang GmbH

See all devices from Leonhard Lang GmbH →

Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of wounds is SKINTACT designed to treat, and how does it promote healing?

    SKINTACT is an occlusive hydrocolloid dressing intended for partial- and full-thickness wounds, including pressure ulcers, venous ulcers, and diabetic foot ulcers. It creates a moist wound environment to support healing by maintaining hydration at the wound site, which helps reduce friction and shear while promoting a cleaner, more conducive environment for tissue regeneration.

  • Is SKINTACT meant for single-use only, and how should it be stored before use?

    Yes, SKINTACT is supplied as a single-use, sterile product, ensuring safety and hygiene for each application. It should be stored according to manufacturer guidelines—typically in a cool, dry place away from direct sunlight—until ready for use, as improper storage could compromise sterility or adhesive properties.

  • What sizes are available for SKINTACT, and how does this accommodate different wound dimensions?

    SKINTACT comes in multiple sizes to fit various wound dimensions, allowing clinicians to select the appropriate size for partial- or full-thickness wounds. The varied sizing ensures proper coverage and adherence, reducing the risk of gaps that could lead to infection or inadequate healing.

  • How is SKINTACT different from other wound dressings, particularly in terms of its adhesive and occlusive properties?

    SKINTACT is a sterile, adhesive hydrocolloid-based dressing that forms a seal over the wound, creating an occlusive environment to retain moisture while protecting against external contaminants. Unlike non-adhesive or semi-permeable dressings, its adhesive nature ensures secure placement, reducing the need for frequent changes and maintaining a consistent healing environment.