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Drew Scientific , Ltd.

USA · Portsmouth

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Russia — 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

9listed device types

Class I 3Class II 6Class III 0

plus 8 registration records and 9 510(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

1active device licences

Class II 1

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

6active registrations

Class 1 4Class 2a 2

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, 9 510(k), 0 PMA, 1 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: JAS Diagnostics/Drew Scientific · DREW SCIENTIFIC INC.

FDA 510(k) clearances by year

21992

11993

11999

12001

12004

12006

22007

FDA listed device types

showing 8 of 9

Counter, Differential Cell 1Calibrator For Platelet Counting 1Calibrator For Red-Cell And White-Cell Counting 1Calibrator For Hemoglobin And Hematocrit Measurement 1Calibrator For Cell Indices 1Mixture, Hematology Quality Control 1Diluent, Blood Cell 1Products, Red-Cell Lysing Products 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K071562	D3 HEMATOLOGY ANALYZER, MODEL D3	2007-12-11
US	K070704	TRILOGY ANALYZER	2007-07-13
US	K060510	DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT	2006-06-19
CA	32874	DS30 HCY HOMOCYSTEINE ASSAY SYSTEM	Class II

Drew Scientific , Ltd.

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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