EU → North America Device Access

Clonit srl

IT-MF-000022196 · Italy · Milano

Clonit srl is registered in the European database on medical devices as a manufacturer, with 39 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: CLONEXT 12 AUTOMATED NUCLEIC ACID PURIFICATION SYSTEM, OP02001-48, OP02002-48, OP02004-48, OP02005-48.

Devices declared under this manufacturer

Showing 12 of 39 declared devices.

Catalogue references include OP01019, OP02001-48, OP02002-48, OP02004-48, OP02005-48, OP02025-48.

European nomenclature codes declared: W0105900101, W0106010401, W02079099, W0105011699, W0106010103, W0105040205.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED39
Country of registrationItaly

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

Device-level evidence

Devices with a numeric GTIN39
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. Clonit srl was not found in either the U.S. or the Canadian register.

Other manufacturers in Italy

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