HomeIrelandGentian Health Ltd.

Gentian Health Ltd.

Ireland · Shannon · www.gentianhealth.com
✓ Record-verifiedregistrations found in 2 marketsEU SRN NO-MF-000003448

This company has registrations in European Union, United Kingdom — 2 overseas markets. 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
16UDI-DI device records
IVD B 16
USUnited StatesFDA openFDA
0listed device types
Class I 0Class II 0Class III 0
plus 0 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
9registered device records
IVD general 9
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 Union16 raw hits, 0 excluded, 16 confirmed
United States0 registration records, 0 510(k), 0 PMA, 2 excluded
United Kingdom9 confirmed, 0 excluded
Brazil0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded

Regulatory identity

EU manufacturer SRN
NO-MF-000003448
UK responsible person
Emergo Consulting (UK) Limited

Company information

Country
Ireland
City
Shannon
Website
www.gentianhealth.com
Product categories
Digital Medicine, Data & Artificial IntelligenceWearables

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.

Business registration

Legal name
GENTIAN HEALTH LIMITED
LEI
894500T03E4RRJ2CGD26
Registration status
Active
Legal form
Teoranta (teo)
Incorporated
2007-09-24
Registered address
4 PERY SQUARE, CO. LIMERICK, LIMERICK, V94 EHE6
Registration authority
Companies Register, no. 446652
Registry record updated
2024-08-30

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

Registration details (sample)

MarketIdentifierNameClass / date
EU07090038460085Gentian Cystain C Control KitIVD B
EU07090038460078Gentian Cystatin C Control KitIVD B
EU17090038460020Gentian Cystatin C Control Kit IVD B
EU07090038460092Gentian Cystatin C CalibratorIVD B
UK53625GCAL® NEPH ImmunoassayIVD general
UK53626GCAL® NEPH ImmunoassayIVD general
UK53627Calprotectin (R1 1x2 mL + R2 3x1.9 mL)IVD general

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