Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016429246

FEI Number

3016429246

Entity Name

KERECIS EHF

City/State/Country

Isafjordur Vestfiroir, IS

Establishment Address

Sundstraeti 38, Isafjordur Vestfiroir 400, IS

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

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

K202430

PMA Number

N/A

All Registered Proprietary Names

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 SurgiBind SurgiBind

Registered Product Listings

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

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
3010600625	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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3031600472	TIGER WOUND CARE MEDICAL, LLC	Conshohocken, PA, US
3009882464	Synergy Health AST, LLC	Saxonburg, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016429246. Last updated year: 2026. Please use registration number 3016429246 when referencing this establishment in official correspondence.