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Home›IDS IMMUNODIAGNOSTIC SYSTEMS LTD.

IDS IMMUNODIAGNOSTIC SYSTEMS LTD.

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Israel — 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
21listed device types
Class I 12Class II 9Class III 0
plus 38 registration records and 27 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
22registered devices
Class I 6Class II 16
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
pendingnot queried
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 States38 registration records, 27 510(k), 0 PMA, 2 excluded
Brazil22 confirmed, 1 excluded
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: IMMUNODIAGNOSTIC SYSTEMS LTD. · Immunodiagnostic Systems SA · IMMUNODIAGNOSTIC SYSTEMS LIMITED · IDS IMMUNODIAGNOSTIC SYSTEMS LTD. · IMMUNODIAGNOSTIC SYSTEMS SA · IDS IMMUNODIAGNOSTIC SYSTEM LTD.
Same-named companies — This database also contains companies with near-identical names: IDS IMMUNODIAGNOSTIC SYSTEM LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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
Radioimmunoassay, Acth 1Calibrator, Secondary 1Electrophoretic Separation, Alkaline Phosphatase Isoenzymes 1Radioimmunoassay, Cortisol 1Radioimmunoassay, Aldosterone 1Radioimmunoassay, Angiotensin I And Renin 1Radioimmunoassay, Parathyroid Hormone 1System, Test, Osteocalcin 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252728IDS-iSYS Total Testosterone2026-04-15
USK240865IDS-iSYS Free Testosterone2024-10-23
USK223867IDS ACTH II2023-08-18
BR10338930358IDS-iSYS Diluent CClass I
BR10338930343FAMÍLIA IDS-iSYS 25 VitDSClass II
BR10338930346Família IDS-iSYS Intact PTHClass II
CA64193GAMMA-BCT DPD RIAClass II
CA64195OCTEIA IGF-1 (INSULIN LIKE GROWTH FACTOR)Class II
CA64188GAMMA-BCT INTACT PTH (PARATHYROID HORMONE)Class II

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