EU → North America Device Access

Absorbest AB

SE-MF-000003933 · Sweden · Kisa

Absorbest AB is registered in the European database on medical devices as a manufacturer, with 12 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb12

Among these devices, 12 are declared sterile.

Devices declared under this manufacturer

Catalogue references include 610111, 610112, 610115, F60913/10, F60914/10, F60915/10.

European nomenclature codes declared: M040499.

United States market access

FDA establishment registerRegistered with FDA
Matched entryABSORBEST AB (SE) · FDA 3008821638
Devices in EUDAMED12
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN12
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: United States only. Absorbest AB is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
28620148569supplemented2027-05-30

Other manufacturers in Sweden

All Sweden manufacturers →