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Promega Corporation

USA · Madison

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, Australia, Israel — 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

6listed device types

Class I 3Class II 1Class III 2

plus 7 registration records and 1 510(k), 1 PMA

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 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

0active device licences

TWTaiwanTFDA

1valid device licences

Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 1 2

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 States7 registration records, 1 510(k), 1 PMA, 1 excluded

Brazil8 confirmed, 0 excluded

Manufacturer names merged into this page: Promega Corporation · PROMEGA CORPORATION

FDA 510(k) clearances by year

12021 · K200129

FDA listed device types

Lynch Syndrome Test System 1Clinical Sample Concentrator 1General Purpose Reagent 1Nucleic Acid Quantitation Kit 1Nucleic Acid Based Assay, Microsatellite Instability 1Kit, Dna Detection, Human Papillomavirus 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200129	OncoMate MSI Dx Analysis System	2021-07-26
BR	80746580002	Manipulador de Líquidos Maxprep	Class I
BR	80146501764	Sample Preparation System DNA	Class I
BR	80146501765	Sample Preparation System RNA	Class I

Promega Corporation

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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