EU → North America Device Access

h/p/cosmos sports & medical gmbh

DE-MF-000006147 · Germany · Nussdorf - Traunstein

h/p/cosmos sports & medical gmbh is registered in the European database on medical devices as a manufacturer, with 81 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIb80
Class IIa1

Most frequent device types declared: body weight support device h/p/cosmos (airwalk), treadmill h/p/cosmos 150/50 (locomotion), treadmill h/p/cosmos 150/50 (pluto, mercury), treadmill h/p/cosmos 170-190/65 (quasar, pulsar), treadmill h/p/cosmos 170-190/65 3p (quasar 3p, pulsar 3p).

Among these devices, 80 are declared active, 80 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 81 declared devices.

Catalogue references include cos30003-01va04, cos30003-01va08, cos30003va03, cos30005-01va03, cos30008-01va04, cos30010-01va01.

European nomenclature codes declared: Z129006, Y050201,Z120602.

United States market access

FDA establishment registerRegistered with FDA
Matched entryH/P/COSMOS SPORTS & MEDICAL GMBH (DE) · FDA 3008309560
Devices in EUDAMED81
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN81
Found in the U.S. device database0
Share0.0 %

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. h/p/cosmos sports & medical gmbh is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
G10 045283 0027issued2027-11-17

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