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IMMY, Inc.

USA · Norman

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Hong Kong — 6 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

25listed device types

Class I 9Class II 16Class III 0

plus 38 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

4 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 1Class III 1

TWTaiwanTFDA

2valid device licences

Class I 2

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 2 1IVD Class 3 1

HKHong KongMDACS

1valid listings

IVD C 1

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 States38 registration records, 0 510(k), 0 PMA

Brazil3 confirmed, 0 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: IMMY, Inc. · IMMY, INC. · IMMY INC

FDA listed device types

showing 8 of 25

Antigen, Elisa, Cryptococcus 1Antiserum, Positive And Negative Febrile Antigen Control Serum 1Enzyme Linked Immunosorbent Assay, Coccidioides Immitis 1Antiserum, Positive Control, Histoplasma Capsulatum 1Antigens, Histoplasma Capsulatum, All 1Antisera, Latex Agglutination, Cryptococcus Neoformans 1Antigen, Latex Agglutination, Coccidioides Immitis 1Eia, Blastomyces Dermatitidis 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	81504790096	Sôna Aspergillus Galactomannan LFA	Class II
BR	81504790336	LFA Cube Reader sona	Class II
BR	81504790103	Clarus Histoplasma Galactomannan EIA	Class II
CA	91758	CRAG LATERAL FLOW ASSAY	Class III
CA	99325	MYCODDR TRIDENT MYCOBACTERIUM DIGESTION AND DECONTAMINATION REAGENT SYSTEM	Class II

IMMY, Inc.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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