Data / Medical devices / Iceland / Kerecis Ehf
Kerecis Ehf: FDA-registered device maker in Isafjordur Vestfiroir, Iceland, 6 510(k) clearances
Kerecis Ehf is registered with the FDA (registration 3016429246) in Isafjordur Vestfiroir, Iceland. It lists 4 device types. The FDA files 6 510(k) clearances under its listings, the newest dated June 4, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016429246
- Address
- Sundstraeti 38, Isafjordur Vestfiroir, Iceland, 400
- Owner or operator
- Kerecis ehf (10045392)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 12, 2013
- Registered through
- 2026
- Brand names listed
- Alphaplex with MariGen Wound, Compact, GraftGuide, GraftGuide Mano, GraftGuide Micro, Kerecis MariGen Compact, Kerecis MariGen Shield, Kerecis Omega3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mesh, Surgical | FTM | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Wound Dressing With Animal-Derived Material(S) | KGN | U | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 4, 2025 | K243843 | Tendon Protect (50242) | OWY | Substantially Equivalent | Kerecis Limited | accessdata.fda.gov |
| August 21, 2024 | K241080 | Kerecis Parvus (50207) | KGN | Substantially Equivalent | Kerecis Limited | accessdata.fda.gov |
| June 29, 2022 | K213231 | Kerecis Silicone | KGN | Substantially Equivalent | Kerecis Limited | accessdata.fda.gov |
| May 2, 2021 | K202430 | Kerecis Reconstruct | OXH | Substantially Equivalent | Kerecis Limited | accessdata.fda.gov |
| July 10, 2019 | K190528 | MariGen Wound Extra | KGN | Substantially Equivalent | Kerecis Limited | accessdata.fda.gov |
| October 23, 2013 | K132343 | MARIGEN WOUND DRESSING | KGN | Substantially Equivalent | Kerecis Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- All makers of Mesh, Surgical
- All makers of Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon
- All makers of Wound Dressing With Animal-Derived Material(S)
Updated June 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.