EU → North America Device Access

Mercado Medic AB

SE-MF-000005191 · Sweden · Lidingö

Mercado Medic AB is registered in the European database on medical devices as a manufacturer, with 1 125 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa1 125

Most frequent device types declared: REAL 6100 PLUS, REAL 8000 PLUS, REAL 9000 PLUS, REAL 9200 TWIN, REAL 9600 PLUS, REAL 9500 PLUS, REAL 2000.

Among these devices, 1 125 are declared active.

Devices declared under this manufacturer

Showing 12 of 1 125 declared devices.

Catalogue references include REAL 6100 PLUS, REAL 8200 PLUS, REAL 9000 PLUS, REAL 9100 PLUS, REAL 9200 TWIN, REAL 9300 PLUS.

European nomenclature codes declared: Y180918, Y122127, V08020101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMERCADO MEDIC AB (SE) · FDA 3015809017
Devices in EUDAMED1 125
Country of registrationSweden

Device-level evidence

Devices with a numeric GTIN1 125
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. Mercado Medic AB is registered in the United States but was not found in the Canadian register.

Other manufacturers in Sweden

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