EU → North America Device Access

Plum Safety ApS

DK-MF-000008672 · Denmark · Assens

Plum Safety ApS is registered in the European database on medical devices as a manufacturer, with 20 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa20

Most frequent device types declared: Bandage, Plaster.

Devices declared under this manufacturer

Showing 12 of 20 declared devices.

Catalogue references include 5508, 5512, 5525, 5526, 5527, 5542.

European nomenclature codes declared: M04010199, M0303010203.

United States market access

FDA establishment registerRegistered with FDA
Matched entryPLUM Safety ApS (DK) · FDA 3005147993
Devices in EUDAMED20
Country of registrationDenmark

Device-level evidence

Devices with a numeric GTIN20
Found in the U.S. device database7
Share35.0 %

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. Plum Safety ApS is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
C590336issued2030-09-18

Other manufacturers in Denmark

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