HomeUSACHRONO LOG CORPORATION

CHRONO LOG CORPORATION

USA · Havertown
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Russia — 7 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
4listed device types
Class I 0Class II 4Class III 0
plus 8 registration records and 16 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
10registered devices
Class II 10
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
4 including historic records
TWTaiwanTFDA
9valid device licences
Class II 9
SGSingaporeHSA SMDR
3device registrations
CLASS B 3
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
IVD Class 1 1IVD Class 2 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
6active registrations
Class 1 2Class 2a 4
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 States8 registration records, 16 510(k), 0 PMA, 1 excluded
Brazil10 confirmed, 0 excluded
Manufacturer names merged into this page: CHRONO-LOG CORP. · CHRONO LOG CORPORATION · CHRONO LOG · CHRONO-LOG CORPORATION

Company information

Country
USA
City
Havertown

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

21976
11977
11978
11982
11983
21985
11992
11993
11994
11995
11996
12004
12005
12016

FDA listed device types

System, Automated Platelet Aggregation 1Reagent, Platelet Aggregation 1Aggregrometer, Platelet 1Test, Qualitative And Quantitative Factor Deficiency 1

Registration details (sample)

MarketIdentifierNameClass / date
USK161329Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel2016-12-02
USK050265CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 7002005-10-14
USK032951CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A2004-04-02
BR10355870002SISTEMA DE AGREGACAO PLAQUETARIA CHRONO-LOGClass II
BR10355870012ACIDO ARAQUIDÔNICOClass II
BR10355870016ADPClass II

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