Skip to content

Acl Elite

by Instrumentation Laboratory Company

Ref 00000880311

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

5 closed

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 Number84269504530177B Basic UDI-DI 08426950453017UDI-DIDate4 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number08426950453017 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 · FDA

  • 5 recalls, same reason

    • Terminated Z-0805-2011 FDA Unclassified (pre-2012) initiated 11 Nov 2010
    • Terminated Z-0807-2011 FDA Unclassified (pre-2012) initiated 11 Nov 2010
    • Terminated Z-0803-2011 FDA Unclassified (pre-2012) initiated 11 Nov 2010
    • Terminated Z-0806-2011 FDA Unclassified (pre-2012) initiated 11 Nov 2010
    • Terminated Z-0804-2011 FDA Unclassified (pre-2012) initiated 11 Nov 2010

    Sporadically lowered APTT results were observed with the PT/APTT Test Groups.

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  • Withdrawn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
Coagulation analyser IVD, laboratory
Model / Ref / Catalog
00000880311
Primary DI / UDI-DI
08426950453017
Basic UDI-DI
84269504530177B
510(k) Number
FDA Product Code
JPA
EMDN Code
W0202020102 Automated coagulometers
GMDN Term
Coagulation analyser IVD, laboratory
Device Class
Class A EUDAMED
Class II GUDID
Regulation Number
864.5425
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
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

  • Professional Testing
  • Surgical Instrument
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No