EU → North America Device Access

Unomedical A/S

DK-MF-000002447 · Denmark · Lejre

Unomedical A/S is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb10

Most frequent device types declared: Soft Cannula Sets Diabetic.

Among these devices, 10 are declared sterile.

Devices declared under this manufacturer

Catalogue references include 1017112, 1017113, 1017127, 1017128, 1017129, 1017130.

European nomenclature codes declared: A03040101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryUNOMEDICAL A/S (DK) · FDA 8021545
Devices in EUDAMED10
Country of registrationDenmark

Device-level evidence

Devices with a numeric GTIN10
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryUNOMEDICAL A/S

North American profile: Both markets. Unomedical A/S is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
39124supplemented2027-08-30

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