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HemosIL UF Heparin Controls

by Instrumentation Laboratory Company

Ref 0020300300

Active European Union. Also listed in GUDID (US).

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

5 ongoing

Recall on shared 510(k) K090209; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number8426950478683AF Basic UDI-DI 08426950478683UDI-DIDate29 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08426950478683 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

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

5 recalls · 5 ongoing · FDA

  • 4 recalls, same reason

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

    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 on shared 510(k) K090209

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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic Name
Heparin anti-Xa IVD, control
Model / Ref / Catalog
0020300300 EUDAMED
00020300300 GUDID
Primary DI / UDI-DI
08426950478683
Basic UDI-DI
8426950478683AF
Direct Marketing DI
08426950478683
510(k) Number
FDA Product Code
GNN
EMDN Code
W0103020702 Control plasma for haemostasis
GMDN Term
Heparin anti-Xa IVD, control
Device Class
Class C EUDAMED
Class I GUDID
Regulation Number
866.3145
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
0020300300
GUDID
00020300300
Device ClassEUDAMED
Class C
GUDID
Class I

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

  • Human Tissues
  • Reagent
  • Professional Testing
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No