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GENBIO

USA · San Diego

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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

9listed device types

Class I 4Class II 5Class III 0

plus 12 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States12 registration records, 10 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: GENBIO

FDA 510(k) clearances by year

21996

21997 · K963054

51998 · K974226

12001 · K010301

FDA listed device types

showing 8 of 9

Antisera, All Groups, Salmonella Spp. 1Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls 1Reagent, Borrelia Serological Reagent 1Antigens, All, Leptospira Spp. 1Anti-Jcv Antibody Detection Assay 1Antisera, All Mycoplasma Spp. 1Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. 1Reagent, Rickettsia Serological 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K010301	IMMUNOWELL EA (D) IGG TEST	2001-06-11
US	K974226	IMMUNODOT MONO-G TEST	1998-09-22
US	K974244	IMMUNODOT MONO-M TEST	1998-09-22
BR	10259610041	ANTICARDIOLIPINA M	Class II
BR	10259610040	ANTICARDIOLIPINA G	Class II

GENBIO

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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