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HemosIL Heparin Calibrators

by Instrumentation Laboratory Company United States EUDAMEDGUDID

Ref 0020300600 Product code JISEMDN W0103020701

Regulatory status

as of 25 Oct 2026

Recall ongoing on a related submission. 5 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number84269504724838T Basic UDI-DIDate29 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08426950472483 UDI-DIDate23 Sep 2016ListedStatusIn 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

Certificates: none listed in EUDAMED

Recalls

5 recalls · 5 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-1304-2023 FDA Class II initiated 3 Feb 2023 via K090209, on the same 510(k)
    • Ongoing Z-1305-2023 FDA Class II initiated 3 Feb 2023 via K090209, on the same 510(k)
    • Ongoing Z-1307-2023 FDA Class II initiated 3 Feb 2023 via K090209, on the same 510(k)
    • Ongoing Z-1306-2023 FDA Class II initiated 3 Feb 2023 via K090209, on the same 510(k)

    Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments

    • Ongoing Z-0149-2022 FDA Class II initiated 25 Aug 2021 via K090209, on the same 510(k)

    Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Generic Name
Heparin anti-Xa IVD, calibrator
Model / Ref / Catalog
0020300600 EUDAMED
00020300600 GUDID
Primary DI / UDI-DI
08426950472483
Basic UDI-DI
84269504724838T
Direct Marketing DI
08426950472483
510(k) Number
FDA Product Code
JIS
EMDN Code
W0103020701 Calibration plasma for haemostasis
GMDN Term
Heparin anti-Xa IVD, calibrator
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
862.1150
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
0020300600
GUDID
00020300600
Device ClassEUDAMED
Class C
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000035586
Authorised representative
Instrumentation Laboratory SpA IT-AR-000008169

Other devices from Instrumentation Laboratory Company

See all devices from Instrumentation Laboratory Company →

Properties & raw data

Show properties, registry sources and raw records
  • Human Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
Other properties (17)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Animal Tissues: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED d188346b-fd6f-45d8-bd63-14a8b89d47c1 61 fields · synced 22 Oct 2026
  • FDA UDI 37fe7214-4332-4b77-b825-bbae16c5a92c 37 fields · synced 30 May 2026