HomeCroatiaBioGnost Ltd.

BioGnost Ltd.

Croatia · Zagreb · www.biognost.com
✓ Record-verifiedregistrations found in 1 marketsEU SRN HR-MF-000022153

This company has registrations in European Union — 1 overseas markets. EU UDI-DI records ≥100, the first 300 verified individually. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
≥100UDI-DI device records
IVD A 100
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

European Union1,127 raw hits, 0 excluded, 100 confirmed. Large result set — only the first 300 verified

Regulatory identity

EU manufacturer SRN
HR-MF-000022153

Company information

Country
Croatia
City
Zagreb
Website
www.biognost.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsPathology & histologyDigital pathology

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Registration details (sample)

MarketIdentifierNameClass / date
EU03858892121542BioSchiff Forte, 500 mLIVD A
EU03858892121535BioSchiff Forte, 100 mLIVD A
EU03858892126059BioSap H, 100 mLIVD A
EU03858892125151BioSap SEA 12.5% suspension, 20 mLIVD A

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