EU → North America Device Access

Aureliym GmbH

DE-MF-000013571 · Germany · Bad Neuenahr-Ahrweiler

Aureliym GmbH is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Most frequent device types declared: SilentCloud.

Among these devices, 7 are declared active.

Devices declared under this manufacturer

Catalogue references include 010, 011, 020, 021, 030, 040.

European nomenclature codes declared: Z12040192.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN7
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryAURELIYM GMBH

North American profile: Canada only. Aureliym GmbH holds a Canadian licence but was not found in the U.S. register.

Notified body certificates

CertificateStatusExpiry
G10 106758 0002issued2027-12-07

Other manufacturers in Germany

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