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Zeus Scientific, Inc.

USA · Raritan

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Israel, Russia — 8 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

59listed device types

Class I 16Class II 40Class III 2unclassified 1

plus 129 registration records and 142 510(k), 5 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class II 8

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

45active device licences

Class II 25Class III 20

96 including historic records

TWTaiwanTFDA

23valid device licences

Class I 5Class II 18

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

5active ARTG entries

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

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 1

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 States129 registration records, 142 510(k), 5 PMA, 1 excluded

Brazil8 confirmed, 0 excluded

Canada45 confirmed, 0 excluded

Manufacturer names merged into this page: ZEUS SCIENTIFIC LLC · ZEUS SCIENTIFIC, INC. · ZEUS SCIENTIFIC, LLC · ZEUS SCIENTIFIC LLC.

FDA 510(k) clearances by year

31995

41996

81997

231998

241999

52000

12001

12002

42004

32005

32007

12008

32010

42011

12012

32019

12022

22023

32025

12026

FDA listed device types

showing 8 of 59

System, Test, Systemic Lupus Erythematosus 1Antibody Igm,If, Cytomegalovirus Virus 1Anti-Human Globulin, Fta-Abs Test 1Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) 1Reagents, Antibody, Legionella, Direct & Indirect Fluorescent 1Anti-Dna Indirect Immunofluorescent Solid Phase 1Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use 1Reagent, Borrelia Serological Reagent 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250814	Alegria Flash SSA-60; Alegria Flash SSA-52; Alegria FLash SSB	2026-05-08
US	K250666	Alegria Flash CTD Screen	2025-10-22
US	K250408	Alegria Flash ENA Screen	2025-09-19
BR	80416660208	Mouse Kidney/Stomach/Liver Tissue	Class II
BR	80416660209	Rat Kidney/Stomach/Liver Tissue	Class II
BR	80416660210	ASA (Monkey Esophagus)	Class II
CA	5902	ANTI-NATIVE DEOXYRIBONUCLEIC ACID NDNA TEST KIT	Class II
CA	9271	EXTRACTABLE NUCLEAR ANTIGEN ENA GEL DIFFUSION TEST KIT	Class II
CA	9358	ANTI-THYROID ANTIBODY (TA) MONKEY THYROID SUBSTRATE IFS TEST KIT 48 TEST, CONJUGATE PACKAGE AND SLIDE PACKAGE	Class II

Zeus Scientific, 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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