Home›France›IMMUNODIAGNOSTIC SYSTEMS FRANCE SAS

IMMUNODIAGNOSTIC SYSTEMS FRANCE SAS

France · Pouilly En Auxois Cote-D'Or

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, 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

21listed device types

Class I 12Class II 9Class III 0

plus 39 registration records and 27 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class I 3Class 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

5active device licences

Class II 5

25 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IVD Class 1 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States39 registration records, 27 510(k), 0 PMA, 1 excluded

Brazil4 confirmed, 3 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: IMMUNODIAGNOSTIC SYSTEMS FRANCE SAS · IMMUNODIAGNOSTIC SYSTEMS LTD. · Immunodiagnostic Systems SA · IMMUNODIAGNOSTIC SYSTEMS LIMITED · IMMUNODIAGNOSTIC SYSTEMS SA · IMMUNODIAGNOSTIC SYSTEMS FRANCE

FDA 510(k) clearances by year

11994

11995

11999

12002

12004

12005

12010

22011

32012

22013

12014

32015

22016

12017

12019

12020

12021

12023

12024

12026

FDA listed device types

showing 8 of 21

Immunoassay, Insulin-Like Growth Factor Binding Protein-1 1Column Chromatography & Color Development, Hydroxyproline 1Radioimmunoassay, Prolactin (Lactogen) 1Radioimmunoassay, Progesterone 1Radioimmunoassay, Estradiol 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Shaker/Stirrer 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252728	IDS-iSYS Total Testosterone	2026-04-15
US	K240865	IDS-iSYS Free Testosterone	2024-10-23
US	K223867	IDS ACTH II	2023-08-18
BR	10338930340	IDS-iSYS Cartridge Check System (CCS)	Class I
BR	10338930341	IDS-iSYS Trigger Set	Class I
BR	10338930342	IDS-iSYS Wash Solution	Class I
CA	64193	GAMMA-BCT DPD RIA	Class II
CA	64195	OCTEIA IGF-1 (INSULIN LIKE GROWTH FACTOR)	Class II
CA	64188	GAMMA-BCT INTACT PTH (PARATHYROID HORMONE)	Class II

IMMUNODIAGNOSTIC SYSTEMS FRANCE SAS

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