EU → North America Device Access

ONCARE GmbH

DE-MF-000007460 · Germany · Munich

ONCARE GmbH is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa7

Among these devices, 7 are declared active.

Devices declared under this manufacturer

Catalogue references include Careplan Manager 1.14, Mobile 1.14, ON01010113, ON01010114, ON01039913, ON01039914.

European nomenclature codes declared: Z12040182, Z12040192.

United States market access

FDA establishment registerRegistered with FDA
Matched entryONCARE GmbH (DE) · FDA 3023709806
Devices in EUDAMED7
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN7
Found in the U.S. device database2
Share28.6 %

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. ONCARE GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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