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IDS High Sensitive Estradiol IS-5200HS

by Immunodiagnostic Systems, Ltd. EUDAMEDGUDID

Active European Union

Ref IS-5200HS

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05060169693630 UDI-DIDate25 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/IVDR EUDAMED Number5060169693630XP Basic UDI-DIDate24 Jun 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
IDS High Sensitive Estradiol
Generic Name
Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
Model / Ref / Catalog
IS-5200HS
Primary DI / UDI-DI
05060169693630
Basic UDI-DI
5060169693630XP
FDA Product Code
CHP
EMDN Code
W0102050103 Estradiol
GMDN Term
Estradiol (oestradiol) (E2) IVD, kit, chemiluminescent immunoassay
Device Class
Class B EUDAMED
Class I GUDID
Regulation Number
862.1260
Market of Registration
Belgium
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Safe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class B
GUDID
Class I

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing
  • New Device
  • Prescription Use
  • Convenience Kit
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No