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KERECIS hf.

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KERECIS hf. is a medical device manufacturer, with 117 devices listed in FDA GUDID (FDA Unclassified and Class II) as of 12 Nov 2026.

Devices
117

Registry facts

Counted by deviCERTS from registry records, 12 Nov 2026

Registries
  • FDA GUDID 117
Device classes
  • FDA Unclassified 99
  • FDA Class II 18
Identifiers
  • DUNS 365732410

What KERECIS hf. makes

The company produces bioabsorbable surgical meshes for extra-gynaecological applications, including collagen-based materials designed for tissue integration. It also manufactures animal-derived wound matrix dressings for skin repair and protection, as well as wound care solutions incorporating omega-3 fatty acids. Surgical closure products, such as absorbable sutures and silicone-based wound sealants, are part of its portfolio, alongside devices for guiding tissue grafts in reconstructive procedures.

These devices are classified under FDA’s Class II and Class U categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States, adhering to applicable US regulatory requirements for medical devices.

AI-generated from registry data, 19 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue117

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Company details

DUNS number
365732410
Phone
7032878752

Frequently asked questions

How many devices does KERECIS hf. have in the registry?

The registry currently lists 117 devices for KERECIS hf.. Devices recorded under merged duplicate company entries are counted once.

Which registries list KERECIS hf.'s devices?

Among its 50 most recently registered devices, KERECIS hf. has devices listed in FDA GUDID (50 devices).

What risk classes do KERECIS hf.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for KERECIS hf.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from KERECIS hf. in the registry?

The most recently registered devices listed for KERECIS hf. include Kerecis SurgiBind® Tendon Protect 3 x 5 cm, Kerecis SurgiBind® Tendon Protect 6 x 9 cm, Kerecis MariGen® 3 x 3.26 cm Fenestrated and Kerecis MariGen® 4 x 5 cm Fenestrated.

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