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Stat Medical Corp.

USA · Mchenry
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 3 registration records and 13 510(k)
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
4active device licences
Class II 4
5 including historic records
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 States3 registration records, 13 510(k), 0 PMA, 12 excluded
Canada4 confirmed, 1 excluded
Manufacturer names merged into this page: STAT MEDICAL DEVICES, INC.
Same-named companies — This database also contains companies with near-identical names: STAT MEDICAL DEVICES, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Mchenry

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

31977
11978
31979 · K792193
21983 · K830713
12009 · K092016
32023 · K230310

FDA listed device types

Multiple Use Blood Lancet For Single Patient Use Only 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Needle, Hypodermic, Single Lumen 1

Registration details (sample)

MarketIdentifierNameClass / date
USK230310STAT Medical Device Lancing System2023-09-08
USK222617EasyTouch Lancing Device2023-03-21
USK223815ONE DROP Lancing Device2023-02-15
CA70410STAT-LET SAFETY LANCETClass II
CA76683SUPER FINE PEN NEEDLEClass II
CA76684PEDI-LET HEEL BLOOD SAMPLING DEVICEClass II

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