EU → North America Device Access

GS Medical

IE-MF-000010064 · Ireland · Dublin

GS Medical is registered in the European database on medical devices as a manufacturer, with 27 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa27

Most frequent device types declared: 20013, 20015, 20016, 20022, 20023.

Among these devices, 14 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 27 declared devices.

Catalogue references include 20012, 20015/W, 20019, 20020, 20020/4, 20021.

European nomenclature codes declared: M0202010101, M020299, M0201050102, M0201050101, M010103, M0202010102.

United States market access

FDA establishment registerRegistered with FDA
Matched entryGS MEDICAL CO., LTD. (KR) · FDA 3005596514
Devices in EUDAMED27
Country of registrationIreland

Device-level evidence

Devices with a numeric GTIN27
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. GS Medical is registered in the United States but was not found in the Canadian register.

Other manufacturers in Ireland

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