EU → North America Device Access

Q3 Medical Germany GmbH

DE-MF-000008095 · Germany · Winsen (Luhe)

Q3 Medical Germany GmbH is registered in the European database on medical devices as a manufacturer, with 2 224 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa782
Class IIb908
Class I534

Most frequent device types declared: 08 APS 07150, 08 QBX 100576F, 12 AHS 05120, 12PVQ020170CPO, 13PVQ100030BPO5F.

Among these devices, 2 224 are declared sterile, 1 674 implantable.

Devices declared under this manufacturer

Showing 12 of 2 224 declared devices.

Catalogue references include 08 APS 07150, 12 AHS 05120, 12PVQ020170CPO, 13PVQ100030BPO5F, 15PVQ012140CPO, 15PVQ050020APO.

European nomenclature codes declared: P070402020102, C010402020101, C010401020101, C010401020501, C0502, C9002.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED2 224
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 GTIN2 224
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: Neither register. Q3 Medical Germany GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

All Germany manufacturers →