EU → North America Device Access

EQUA OÜ

EE-MF-000000705 · Estonia · Tartu

EQUA OÜ is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa28

Most frequent device types declared: EQUA Premium, EQUA-1402, EQUA-1932, H711031-8, H711032-8.

Among these devices, 3 are declared active.

Devices declared under this manufacturer

Showing 12 of 28 declared devices.

Catalogue references include EQUA-1400, EQUA-1500, EQUA-1913, H711032-8, H711033, H71108.

European nomenclature codes declared: T030199, Y181803, Y180918, Z120602, Y120606, Y180980.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED28
Country of registrationEstonia

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN28
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. EQUA OÜ was not found in either the U.S. or the Canadian register.

Other manufacturers in Estonia

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