HomeUnited Kingdom of Great Britain and Northern IrelandImmunodiagnostic Systems Limited

Immunodiagnostic Systems Limited

United Kingdom of Great Britain and Northern Ireland · Boldon
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Singapore, 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
23registered devices
Class I 6Class II 17
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
4device registrations
CLASS B 4
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
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
Brazil23 confirmed, 0 excluded
Canada5 confirmed, 0 excluded
Manufacturer names merged into this page: IMMUNODIAGNOSTIC SYSTEMS FRANCE SAS · IMMUNODIAGNOSTIC SYSTEMS LTD. · Immunodiagnostic Systems SA · IMMUNODIAGNOSTIC SYSTEMS LIMITED · IDS IMMUNODIAGNOSTIC SYSTEMS LTD. · IMMUNODIAGNOSTIC SYSTEMS SA
Same-named companies — This database also contains companies with near-identical names: IMMUNODIAGNOSTIC SYSTEMS FRANCE SAS. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
United Kingdom of Great Britain and Northern Ireland
City
Boldon

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.

Business registration

Company number
03141527
Registration status
Active
Legal form
Private Limited Company
Incorporated
1995-12-27
Principal activity
32990 - Other manufacturing n.e.c.
Registered address
10 DIDCOT WAY, BOLDON, NE35 9PD

Business registration data from UK Companies House, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

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)

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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