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Nova Biomedical Corporation

USA · Waltham

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

57listed device types

Class I 23Class II 33Class III 1

plus 199 registration records and 129 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

88registered devices

Class I 1Class II 87

112 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

48active device licences

Class II 32Class III 16

66 including historic records

TWTaiwanTFDA

17valid device licences

Class I 5Class II 12

SGSingaporeHSA SMDR

7device registrations

CLASS C 7

KRSouth KoreaMFDS GMP

4GMP quality-system certificates

IVD import 4

AUAustraliaTGA ARTG

10active ARTG entries

IVD Class 1 2IVD Class 2 6IVD Class 3 2

HKHong KongMDACS

1valid listings

IVD C 1

ILIsraelAMAR

10registrations

RURussiaRoszdravnadzor

14active registrations

Class 1 5Class 2a 9

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 States199 registration records, 129 510(k), 0 PMA, 36 excluded

Brazil88 confirmed, 5 excluded

Saudi Arabia0 confirmed, 2 excluded

Canada48 confirmed, 6 excluded

Manufacturer names merged into this page: Nova Biomedical Corporation · NOVA BIOMEDICAL CORPORATION · NOVA BIOMEDICAL CORPORATION DIABETES PRODUCTS · NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA

FDA 510(k) clearances by year

12001

62002

22004

22006

42007

22010

22011

32012

22013

32014

42015

32016

42017

72018

22019

42020

12022

12023

32024

22026

FDA listed device types

showing 8 of 57

System, Hemoglobin, Automated 1Alkaline Picrate, Colorimetry, Creatinine 1Calibrator, Secondary 1Electrode, Ion-Specific, Chloride 1Electrode, Ion Specific, Urea Nitrogen 1Calibrator For Hemoglobin And Hematocrit Measurement 1Oxyhemoglobin 1Ph Rate Measurement, Carbon-Dioxide 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251281	Nova Max Creat eGFR Monitoring System	2026-01-21
US	K252206	Nova Allegro UACR Assay, Nova Allegro Analyzer	2026-01-09
US	K221326	Nova Allegro HbA1c Assay, Nova Allegro Analyzer	2024-11-22
BR	81175310076	Analisador Stat Profile Prime® Plus	Class II
BR	81175310073	Stat Profile Prime Plus® Chemistry Controls 4 and 5	Class II
BR	81175310104	Allegro® Lipids Control Solution	Class II
CA	36482	STAT PROFILE PHOX BASIC ANALYZER	Class III
CA	36483	NOVA CO-OXIMETER SYSTEM	Class II
CA	36484	STAT PROFILE PHOX CO-OXIMETER SYSTEM	Class II