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Biogenex Laboratories, Inc.

USA · Fremont

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, Israel — 4 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

36listed device types

Class I 34Class II 2Class III 0

plus 36 registration records and 12 510(k), 1 PMA

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

240active device licences

Class II 240

285 including historic records

TWTaiwanTFDA

7valid device licences

Class I 7

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

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 States36 registration records, 12 510(k), 1 PMA, 1 excluded

Canada240 confirmed, 0 excluded

Manufacturer names merged into this page: BIOGENEX LABORATORIES INC.

FDA 510(k) clearances by year

11981

31982

11983

11987

11988

11989

11990

11993

22002

FDA listed device types

showing 8 of 36

Iron Stains 1Solution, Silver Carbonate 1Stains, Microbiologic 1Toluidine Blue 1Immunohistochemistry Reagents And Kits 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Hematoxylin Mayer'S 1Mucicarmine 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K012960	BIOGENEX MONOCLONAL ANTI-PROGESTERONE RECEPTOR	2002-03-08
US	K013148	BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88)	2002-02-28
US	K925189	PREGNAGEN 1-STEP PREGNANCY TEST	1993-01-06
CA	60322	CYTOKERATIN 8 AND 18, MONOCLONAL ANTIBODY CLONE 5D3	Class II
CA	60323	CDW75 (B CELL), MONOCLONAL ANTIBODY LN1	Class II
CA	60324	MELANOMA, MONOCLONAL ANTIBODY HMB45	Class II

Biogenex Laboratories, 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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