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Home›USA›Trinity Biotech (Primus Corporation, Dba Trinity Biotech)

Trinity Biotech (Primus Corporation, Dba Trinity Biotech)

USA · Kansas City
✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Taiwan, Hong Kong — 4 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
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 1Class II 2Class III 0
plus 4 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class II 5
7 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
3valid device licences
Class I 1Class II 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
1valid listings
IVD B 1
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.

United States4 registration records, 2 510(k), 0 PMA, 11 excluded
Brazil5 confirmed, 0 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 2 excluded
Manufacturer names merged into this page: Trinity Biotech (Primus Corporation dba Trinity Biotech) · TRINITY BIOTECH PRIMUS CORPORATION DBA TRINITY BIOTECH
Same-named companies — This database also contains companies with near-identical names: Primus Corporation Dba Trinity Biotech. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Kansas City

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.

FDA 510(k) clearances by year

12011 · K112015
12023 · K222635

FDA listed device types

Assay, Glycosylated Hemoglobin 1Abnormal Hemoglobin Quantitation 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1

Registration details (sample)

MarketIdentifierNameClass / date
USK222635Premier Resolution System2023-08-04
USK112015PREMIER HB9210 HBA1C ANALYZER2011-11-22
BR81733730021Família Premier Hb9210 Coluna Analítica HbA1cClass II
BR81733730008HEMOGLOBINA A1c CALIBRADORESClass II
BR81733730009HEMOGLOBINA A1c CONTROLESClass II

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