EU → North America Device Access

AD Nucleis

FR-MF-000002215 · France · GREZIEU LA VARENNE

AD Nucleis is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Most frequent device types declared: AD Nucléis direct SARS-CoV-2_1-step RTCPR, Extraction and purification kit of NA for blood, Sequence.

Devices declared under this manufacturer

Catalogue references include HQS_DICoV2_IVD48R, HQS_DICoV2_IVD96R, KIT-EP_14_112_I_PF, KIT-EP_24_112_I_PF, Kit-EP_96_112_I_PF, SEQ_EVO_IVD.

European nomenclature codes declared: W0105900101, W0105041106, W02050116, W02060101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
Country of registrationFrance

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

Device-level evidence

Devices with a numeric GTIN7
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. AD Nucleis was not found in either the U.S. or the Canadian register.

Other manufacturers in France

All France manufacturers →