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BIONOSTICS, INC.

USA · Devens

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Israel — 7 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

27listed device types

Class I 8Class II 19Class III 0

plus 67 registration records and 49 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

2active device licences

Class II 1Class III 1

5 including historic records

TWTaiwanTFDA

26valid device licences

Class I 26

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 1 1IVD Class 2 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States67 registration records, 49 510(k), 0 PMA

Brazil1 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: BIONOSTICS, INC. · BIONOSTICS INC · BIONOSTICS, INC

FDA 510(k) clearances by year

21990

21991

21992

11994

11995

11996

11997

11998

22000

32001

52002

22003

22005

22006

32008

12009

12010

32011

12012

32013

FDA listed device types

showing 8 of 27

Osmolality Of Tears 1Calculator/Data Processing Module, For Clinical Use 1Acid, Lactic, Enzymatic Method 1Tube, Collection, Capillary Blood 1Controls For Blood-Gases, (Assayed And Unassayed) 1Multi-Analyte Controls, All Kinds (Assayed) 1Drug Mixture Control Materials 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K131136	GLUCOSE METER-CHECK SOLUTION FOR TAIDOC	2013-05-31
US	K123851	GLUCOSE METER-CHECK SOLUTION FOR ROCHE ACCU-CHEK	2013-02-14
US	K123966	GLUCOSE METER-CHECK SOLUTION FOR BAYER	2013-01-25
BR	80146501425	GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROL - CONTROLE PARA	Class II
CA	62122	RNA MEDICAL GLUCOSE CALIBRATION VERIFICATION CONTROL	Class III
CA	72672	HBA1C CONTROLS	Class II

BIONOSTICS, 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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