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HemosIL von Willebrand Factor Activity

by Instrumentation Laboratory Company United States EUDAMED510(k)GUDID

Ref 0020004700 Product code GGPEMDN W0103020217

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number84269500789518V Basic UDI-DIDate29 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08426950078951 UDI-DIDate23 Sep 2016ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK040843 Date30 Apr 2004IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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 America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/IVDR Active

Certificates: none listed in EUDAMED

Recalls

1 recall · FDA

    • Terminated Z-1519-2012 FDA Not yet classified initiated 11 Apr 2012

    Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay.

Specification

EUDAMED · 510(k) · GUDID · synced 23 Oct 2026

Generic Name
von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, kit, nephelometry/turbidimetry
Model / Ref / Catalog
0020004700 EUDAMED
00020004700 GUDID
Primary DI / UDI-DI
08426950078951
Basic UDI-DI
84269500789518V
Direct Marketing DI
08426950078951
510(k) Number
FDA Product Code
GGP
EMDN Code
W0103020217 Coagulation factor von willebrand activity / ristocetin cofactor activity (rco)
GMDN Term
von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) IVD, kit, nephelometry/turbidimetry
Device Class
Class B EUDAMED
Class II GUDID
Regulation Number
864.7290
Market of Registration
Italy
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
0020004700
GUDID
00020004700
Device ClassEUDAMED
Class B
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
  • Animal 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
  • Human 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 (3)

  • EUDAMED 68d939e9-2e35-491d-a6b4-92a4962e889d 61 fields · synced 23 Oct 2026
  • FDA UDI 30c3d7e6-0486-4c5c-ae93-324c7ae6b09d 37 fields · synced 30 May 2026
  • FDA 510(k) K040843 1 fields · synced 18 May 2026