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Selomas, Inc.

United StatesFDA applicant, unverified

Devices
7

What Selomas, Inc. makes

Selomas, Inc. manufactures medical dressings and wound care products, including silicone-based adhesive plasters (e.g., SILKAFIX ADHESIVE PLASTER), USP-compliant gauze sponges (e.g., GAUZE SPONGES USP TYPE VII), and silicone wound sealants (e.g., SELOPOR, SELOFIX). The company also produces wound closure and protection devices like VITASAN and OPRAFLEX, as well as a silicone-based wound dressing system (VITOFIT).

The company’s portfolio includes devices classified as Class I and Unclassified (U), with products authorised via the FDA’s 510(k) pathway. These products are listed under the FDA’s regulatory framework and are intended for use in wound care and skin protection applications.

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

Catalogue7

Newest first, rows 1-7 of 7

  • Vitasan Ref K821259

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

  • Silkafix Adhesive Plaster Ref K821490

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

  • Gauze Sponges Usp Type Vii Ref K861215

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

  • Selopor Ref K821258

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

  • Selofix Ref K821257

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

  • Opraflex Ref K812501

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

  • Vitofit Ref K821260

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

Frequently asked questions

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

The registry currently lists 7 devices for Selomas, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Selomas, Inc.'s devices?

Among its 7 most recently registered devices, Selomas, Inc. has devices listed in FDA 510(k) (7 devices).

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

Among its 7 most recently registered devices, the classes recorded for Selomas, Inc.'s devices are Class I. Each device page shows its own class and authorisation.

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

The most recently registered devices listed for Selomas, Inc. include VITASAN, SILKAFIX ADHESIVE PLASTER, GAUZE SPONGES USP TYPE VII and SELOPOR.

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