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GeneOhm Sciences Canada, ULC.

Canada · Quebec

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Canada, Taiwan, South Korea — 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

18listed device types

Class I 4Class II 13Class III 0unclassified 1

plus 25 registration records and 9 510(k)

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

2active device licences

Class III 2

8 including historic records

TWTaiwanTFDA

11valid device licences

Class II 10Class III 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 1IVD import 2

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 States25 registration records, 9 510(k), 0 PMA, 1 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: GeneOhm Sciences Canada, ULC. · GENEOHM SCIENCES CANADA, INC.

Same-named companies — This database also contains companies with near-identical names: Bd Diagnostics (Geneohm Sciences Canada, Inc), Geneohm Sciences Canada, Inc., Geneohm Sciences Canada, Inc. (Bd Diagnostics), Geneohm Sciences Canada, Inc. (Bd Life Sciences). Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12006

12007

12012

32013

12016

12019

12021

FDA listed device types

showing 8 of 18

Clinical Sample Concentrator 1General Purpose Reagent 1Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test 1Dna Probe, Nucleic Acid Amplification, Chlamydia 1Dna-Reagents, Neisseria 1Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System 1Real Time Nucleic Acid Amplification System 1C. Difficile Toxin Gene Amplification Assay 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K201017	BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit	2021-10-18
US	K191957	BD MAX Vaginal Panel	2019-10-21
US	DEN160001	BD MAX Vaginal Panel, BD MAX Instrument	2016-10-28
CA	89603	BD MAX MRSA ASSAY	Class III
CA	63391	BD GENEOHM MRSA	Class III

GeneOhm Sciences Canada, ULC.

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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