EU → North America Device Access

AKRUS GmbH & Co. KG

DE-MF-000005262 · Germany · Elmshorn

AKRUS GmbH & Co. KG 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: Accessory to instrument delivery table, Doctor stool, Examination chair, Instrument Delivery Table, Mobile Operating Tables.

Among these devices, 12 are declared active.

Devices declared under this manufacturer

Showing 12 of 20 declared devices.

Catalogue references include 242.000000, 277.000000, 277.032020, 280.000000 / 280.W0X0YZ; W,X,Y,Z=0,1,...,9, 288.000000, 470.032000.

European nomenclature codes declared: Z12011201, Z12129001, V080202, Z12011202, V08020101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryAKRUS GmbH & Co. KG (DE) · FDA 3006142326
Devices in EUDAMED20
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN20
Found in the U.S. device database15
Share75.0 %

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. AKRUS GmbH & Co. KG is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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