Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009750086

FEI Number

3009750086

Entity Name

ABIGO MEDICAL AB

City/State/Country

ASKERSUND Orebro, SE

Establishment Address

VAPENVAGEN 1, ASKERSUND Orebro 696 33, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ABIGO MEDICAL AB (Owner Number: 9004891)

Owner / Operator Contact Address

Vapenvagen 1, --, Askersund, SE-NOTA 696 33, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171225

PMA Number

N/A

All Registered Proprietary Names

Cutimed Sorbact Gel Sorbact Leukomed Sorbact Cutimed Sorbact Dressing Pad Cutimed Sorbact WCL Cutimed Sorbact Swab Sorbact Cutimed Sorbact Ribbon

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2012-09-19
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2007-10-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2017-11-29

Official Correspondent

Marie Skoglund

US Agent Details

SEAN ANDERSON Business: BSN Medical Inc Email: sean.anderson@essity.com Phone: (959) 5997401

Related Public Records

Same Entity

ABIGO MEDICAL AB

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
8043991	ABIGO MEDICAL AB	MOLNDAL Vastra Gotaland, SE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

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3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009750086. Last updated year: 2026. Please use registration number 3009750086 when referencing this establishment in official correspondence.