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Biomerica, Inc.

USA · Irvine

✓ Record-verifiedregistrations found in 5 markets

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

28listed device types

Class I 3Class II 22Class III 0unclassified 3

plus 32 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

6registered devices

Class II 6

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

6active device licences

Class II 6

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

7active registrations

Class 1 6Class 2a 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 States32 registration records, 10 510(k), 0 PMA, 1 excluded

Brazil6 confirmed, 0 excluded

Canada6 confirmed, 0 excluded

Manufacturer names merged into this page: Biomerica · BIOMERICA INC. · BIOMERICA, INC. · BIOMERICA

Business registration

Legal name: BIOMERICA INC
CIK: 0000073290
Registration status: Active
Listing status: Listed (BMRA)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

11991

11992

11994

21995

21996

11998

12001

12023

FDA listed device types

showing 8 of 28

Kit, Test, Pregnancy, Hcg, Over The Counter 1Enzyme Immunoassay, Opiates 1Enzyme Immunoassay, Benzodiazepine 1Radioimmunoassay, Acth 1Calibrator, Secondary 1Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers 1Reagent, Occult Blood 1Enzyme Immunoassay, Amphetamine 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232892	Hp Detect Stool Antigen ELISA	2023-12-15
US	K003856	EZ-HCG URINE(PREGNANCY TEST)	2001-02-21
US	K982954	FREE T4 MICROWELL EIA, MODEL #7019	1998-09-24
BR	10300390483	ACTH	Class II
BR	10300390497	INTACT PTH	Class II
BR	10300390485	GAD	Class II
CA	84879	ALLERQUANT IGG ELISA	Class II
CA	88979	CALCITONIN ELISA	Class II
CA	88980	PTH ELISA	Class II

Biomerica, Inc.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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