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Princeton BioMeditech Corp.

USA · Monmouth Junction

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, South Korea, Australia, Israel — 5 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

43listed device types

Class I 7Class II 32Class III 1unclassified 3

plus 200 registration records and 72 510(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

0active device licences

21 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 2 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States200 registration records, 72 510(k), 0 PMA, 1 excluded

Manufacturer names merged into this page: Princeton BioMeditech Corp. · PRINCETON BIOMEDITECH CORP. · PRINCETON BIOMEDITECH CORP

FDA 510(k) clearances by year

11994

121995

101996

41997

101998

121999

12000

72002

12003

12004

12006

22007

22008

32010

22013

12014

12018

12025

FDA listed device types

showing 8 of 43

Chromatographic Separation, Cpk Isoenzymes 1Kit, Test, Pregnancy, Hcg, Over The Counter 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Devices Detecting Influenza A, B, And C Virus Antigens 1Thin Layer Chromatography, Methamphetamine 1System, Test, Infectious Mononucleosis 1Test, Natriuretic Peptide 1

Market	Identifier	Name	Class / date
US	K251538	Status COVID-19/Flu A&B	2025-11-14
US	K182157	BioSign Flu A+B	2018-09-18
US	K130650	STATUS DS OXY	2014-02-26

Princeton BioMeditech Corp.

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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