HomeUSAITC-INTERNATIONAL TECHNIDYNE CORP.

ITC-INTERNATIONAL TECHNIDYNE CORP.

USA
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
48510(k) clearances
Class I 0Class II 0Class III 0
plus 0 registration records and 48 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class II 3
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
1active device licences
Class II 1
2 including historic records
TWTaiwanTFDA
0valid device licences
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 States0 registration records, 48 510(k), 0 PMA, 1 excluded
Brazil3 confirmed, 0 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: INTERNATIONAL TECHNIDYNE CORP. · INTERNATIONAL TECHNIDYNE CORPORATION · ITC-INTERNATIONAL TECHNIDYNE CORP.
Same-named companies — This database also contains companies with near-identical names: International Technidyne Corporation. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA

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

11983
11985
11987
31988
11989
21990
81991
31992
41993
61994
31995
11996
21997
21998
21999
22001
12002
22003
22005
12013

Registration details (sample)

MarketIdentifierNameClass / date
USK120977DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC2013-07-03
USK050983IRMA TRUPOINT CREATININE CONTROL KIT2005-05-16
USK050016HEMOCHRON SIGNATURE ELITE2005-02-10
BR80050170016HEMOCHRON JR SIGNATURE PLUSClass II
BR80050170014SURGICUTT APARELHO DE INCISAO PARA DETERMINACAO DE TEMPO DE COAGULACAOClass II
BR80050170015TENDERFOOT APARELHO DE INCISAO PARA TESTE DO PEZINHOClass II
CA9612SUPERSERUMClass II

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