Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010600625

FEI Number

3010600625

Entity Name

KERECIS EHF

City/State/Country

Isafjordur Vestfiroir, IS

Establishment Address

Eyrargata 2, Isafjordur Vestfiroir 400, IS

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Kerecis ehf (Owner Number: 10045392)

Owner / Operator Contact Address

Eyrargata 2, Isafjordur, IS-4 400, IS

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132343

PMA Number

N/A

All Registered Proprietary Names

Kerecis Omega3 SurgiBind SurgiBind Kerecis Omega3 OR MariGen Wound Extra Kerecis Omega3 Burn SurgiClose Micro Kerecis Omega3 SurgiClose Kerecis Omega3 SurgiClose Micro Kerecis Omega3 GraftGuide Kerecis Omega3 MicroGraft SurgiClose GraftGuide GraftGuide Mano Mano GraftGuide Micro Shield Adhesive Kerecis Shield Adhesive Shield Kerecis Shield Standard Kerecis SurgiClose SurgiClose Silicone Kerecis Shield Kerecis SurgiClose Silicone Kerecis Shield Spiral Shield Standard MariGen Shield Kerecis Omega3 MariGen Shield Shield Spiral Kerecis MariGen Shield SurgiClose Kerecis Omega3 Wound MariGen Alphaplex with MariGen Wound Marigen Omega3 Kerecis Omega3 Marigen Omega3 Wound MariGen Wound Kerecis Omega3 MariGen Expanse Marigen Micro MariGen Expanse Kerecis Omega3 MariGen Kerecis Omega3 MariGen Micro

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OXH	Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	General, Plastic Surgery	Class 2	878.3300	2021-08-25
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2019-10-21
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2022-07-14
KGN	Wound Dressing With Animal-Derived Material(S)	Unknown	Class U	N/A	2013-11-12

Official Correspondent

No official correspondent registered.

US Agent Details

Brynjar Arnarson Business: Kerecis LLC Email: ba@kerecis.com Phone: (703) 2878752

Related Public Records

Same Entity

Kerecis ehf

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016429246	KERECIS EHF	Isafjordur Vestfiroir, IS

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K112888	Kensey Nash Corporation	MESO WOUND MATRIX	2012-02-10
K040211	Collagen Matrix, Inc.	MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING	2004-02-27

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3004464325	DEPUY ORTHOPAEDICS	BRIDGEWATER, MA, US
3005636544	BARD SHANNON LIMITED	Humacao, PR, US
3003418325	Integra LifeSciences Corporation	Princeton, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010600625. Last updated year: 2026. Please use registration number 3010600625 when referencing this establishment in official correspondence.