IMMUNOTECH s.r.o.

Czech Republic · Praha

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Israel, Russia — 8 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 5Class II 1Class III 0

plus 7 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class II 10

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

3active device licences

Class II 3

17 including historic records

TWTaiwanTFDA

45valid device licences

Class II 45

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 1Class 2a 2

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), 0 PMA, 4 excluded

Brazil10 confirmed, 6 excluded

Canada3 confirmed, 1 excluded

Manufacturer names merged into this page: IMMUNOTECH s.r.o. · IMMUNOTECH S.R.O.

FDA 510(k) clearances by year

12019 · K191350

FDA listed device types

Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry 1Radioimmunoassay, Estradiol 1Radioimmunoassay, Estrone 1Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) 1Radioimmunoassay, Testosterones And Dihydrotestosterone 1Radioimmunoassay, Aldosterone 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K191350	ACTIVE® Free Testosterone RIA	2019-12-20
BR	81678060013	17OH PROGESTERONA RIA KIT	Class II
BR	81678060011	ESTRONA RIA KIT	Class II
BR	81678060014	CORTISOL RIA KIT	Class II
CA	82453	INSULIN(E) IRMA KIT	Class II
CA	107377	CHROMOGRANIN A ELISA	Class II
CA	107390	25-OH VITAMIN D TOTAL ELISA	Class II

IMMUNOTECH s.r.o.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies