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IDS-iSYS Free Testosterone Control Set

by Immunodiagnostic Systems Limited United Kingdom EUDAMEDGUDID

Ref IS-5330 Product code JJXEMDN W0102152008

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED NumberB-05060169691247 Basic UDI-DIDate23 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060169691247 UDI-DIDate3 Nov 2025ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 25 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 25 Oct 2026

Generic Name
Free testosterone IVD, control
Device Name
IDS-iSYS Free Testosterone
Model / Reference
IS-5330
Primary DI / UDI-DI
05060169691247
Basic UDI-DI
B-05060169691247, 5060169691230WM
FDA Product Code
JJX
EMDN Code
W0102152008 Controls for individual and specific hormones
GMDN Term
Free testosterone IVD, control
Device Class
Class IVD General EUDAMED
Class B EUDAMED
Class I GUDID
Regulation Number
862.1660
Market of Registration
Belgium
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
Class B
GUDID
Class I

Manufacturer details

EUDAMED SRN
GB-MF-000015851
Authorised representative
Immunodiagnostic Systems SA BE-AR-000015342

Other devices from Immunodiagnostic Systems Limited

See all devices from Immunodiagnostic Systems Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Human Tissues
  • Animal Tissues NoEUDAMEDYesEUDAMED
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
Other properties (14)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (3)

  • EUDAMED 9ec341f8-b1ae-417c-a7cf-2aad00155971 61 fields · synced 22 Oct 2026
  • FDA UDI 2a8f27d2-6138-40f0-9255-0aa97ddd3822 34 fields · synced 22 Oct 2026
  • EUDAMED 05060169691247|5060169691230WM 61 fields · synced 25 Oct 2026