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International Isotopes, Inc.

USA · Denton

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Australia — 3 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

2510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class I 7Class II 5

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

Class I 8

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 States0 registration records, 2 510(k), 0 PMA, 1 excluded

Brazil12 confirmed, 1 excluded

Manufacturer names merged into this page: INTERNATIONAL ISOTOPES, INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K992963	I3RAD 125 I BRACHYTHERAPY SEED, MODEL I125-0401	1999-09-21
US	K982421	IMAGYN 125 I SEED, MODEL IS 125	1998-07-31
BR	81805240001	FONTES RADIOATIVAS PARA CALIBRAÇÃO E CONTROLE DE QUALIDADE PARA CALIBR	Class I
BR	81805240002	FONTES RADIOATIVAS DE EURÓPIO PARA TESTES DE VERIFICAÇÃO E CONTROLE DE	Class I
BR	81805240003	FONTES RADIOATIVAS DE BÁRIO PARA TESTES DE VERIFICAÇÃO E CONTROLE DE Q	Class I

International Isotopes, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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