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STAT MEDICAL DEVICES, INC.

USA · North Miami

✓ 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 8 510(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

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 States3 registration records, 8 510(k), 0 PMA, 13 excluded

Canada4 confirmed, 1 excluded

Manufacturer names merged into this page: STAT MEDICAL DEVICES, INC.

FDA 510(k) clearances by year

31977 · K771030

11978 · K780171

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)

Market	Identifier	Name	Class / date
US	K230310	STAT Medical Device Lancing System	2023-09-08
US	K222617	EasyTouch Lancing Device	2023-03-21
US	K223815	ONE DROP Lancing Device	2023-02-15
CA	70410	STAT-LET SAFETY LANCET	Class II
CA	76683	SUPER FINE PEN NEEDLE	Class II
CA	76684	PEDI-LET HEEL BLOOD SAMPLING DEVICE	Class II

STAT MEDICAL DEVICES, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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