EU → North America Device Access

BioGnost Ltd.

HR-MF-000022153 · Croatia · Zagreb

BioGnost Ltd. is registered in the European database on medical devices as a manufacturer, with 1 127 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Devices declared under this manufacturer

Showing 12 of 1 127 declared devices.

Catalogue references include FMK5-OT-100, IHC-HEM-1L, LDW-100T, O2-P-25, OGEA50-OT-1L, TB-OT-250.

European nomenclature codes declared: W01030708, W0104080299, W01030799, W01030707, W0103010302, W01030705.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 127
Country of registrationCroatia

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

Device-level evidence

Devices with a numeric GTIN1 127
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingSimilar name found — unverified
Matched entryBIOGNOSTICS INC.

⚠️ A similar name exists; unverified — why.

Other manufacturers in Croatia

All Croatia manufacturers →