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Immunotech Corp.

USA · Boston

✓ Record-verifiedregistrations found in 4 markets

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

40510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 40 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

8active ARTG entries

IVD Class 2 8

HKHong KongMDACS

6valid listings

IVD B 6

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 States0 registration records, 40 510(k), 0 PMA, 4 excluded

Brazil1 confirmed, 6 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: IMMUNOTECH

Registration details (sample)

Market	Identifier	Name	Class / date
US	K954188	OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL	1995-11-03
US	K946335	OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES	1995-10-20
US	K953498	OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL	1995-09-08
BR	81678060003	FT4 RIA KIT	Class II

Immunotech Corp.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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