EU → North America Device Access

HidraMed Solutions Limited

IE-MF-000000089 · Ireland · Galway

HidraMed Solutions Limited is registered in the European database on medical devices as a manufacturer, with 30 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa30

Most frequent device types declared: GAX001-02, GAX002-04, GBB001-C01, GBB001-C03, GBB002-01.

Devices declared under this manufacturer

Showing 12 of 30 declared devices.

Catalogue references include GAX001-02, GAX002-04, GBB001-C01, GBB001-C03, GBB002-01, GBB002-02.

European nomenclature codes declared: M0303010101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryHIDRAMED SOLUTIONS LIMITED (IE) · FDA 3016629854
Devices in EUDAMED30
Country of registrationIreland

Device-level evidence

Devices with a numeric GTIN30
Found in the U.S. device database20
Share66.7 %

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. HidraMed Solutions Limited is registered in the United States but was not found in the Canadian register.

Other manufacturers in Ireland

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