HomeUSAH&H Control Systems

H&H Control Systems

USA · Jackson
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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 82 510(k), 30 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
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.

United States4 registration records, 82 510(k), 30 PMA, 50 excluded
Brazil0 confirmed, 3 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada0 confirmed, 6 excluded
Manufacturer names merged into this page: Analytical Control Systems
Same-named companies — This database also contains companies with near-identical names: Analytical Control Systems, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Jackson

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

11984
51985
41986
21987
61988
91989
81990
151991
21992
51993
31994
31995
11996
21997
11998
32002
32003
12004
12005
12006

FDA listed device types

Single (Specified) Analyte Controls (Assayed And Unassayed) 1Whole Blood Hemoglobin Determination 1Calibrator, Primary 1

Registration details (sample)

MarketIdentifierNameClass / date
USK060573BURBANK TENACULUM2006-04-21
USK052209VCS DOPPLER TRANSCEIVER, MODEL 09-0023-012005-09-06
USK032125CSTAT, MODELS 09-0014-01 AND 09-0014-022004-02-09

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