EU → North America 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: Cabinets, Instrument, ENT treatment unit, Endoscope, rigid, Equipment Rails, Flowmeter, gas.

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

Devices declared under this manufacturer

Showing 12 of 652 declared devices.

Catalogue references include 105.2014.5, 313.0160.0, 534.3055.0, 538.2800.0, 538.9100.0, 542.0000.0.

European nomenclature codes declared: V0880, Z120105, A06030401, A060102, V80, Z120309.

United States market access

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

Device-level evidence

Devices with a numeric GTIN652
Found in the U.S. device database43
Share6.6 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryATMOS MEDIZINTECHNIK GMBH & CO. KG

North American profile: Both markets. ATMOS MedizinTechnik GmbH & Co. KG is registered in both the United States and Canada.

Notified body certificates

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

Other manufacturers in Germany

All Germany manufacturers →