EU → US Device Access

ATMOS MedizinTechnik GmbH & Co. KG

DE-MF-000005570 · Germany · Lenzkirch

ATMOS MedizinTechnik GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 652 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa645
Class IIb7

Most frequent device types declared: Flowmeter, gas, Medical gas supply system, component, terminal unit, Suction unit, surgical, Suction unit, tracheal, Suction unit, gas powered.

Among these devices, 20 are declared sterile, 238 active.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerRegistered with FDA
Matched entryATMOS MEDIZINTECHNIK GMBH & CO. KG (DE) · FDA 8010573
Devices in EUDAMED652
Country of registrationGermany

Notified body certificates

CertificateStatusExpiry
G15 010162 0603supplemented2031-02-10
50581-60-00-00issued2031-06-24

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