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ACL ELITE Pro Refurbished

by Instrumentation Laboratory Company

Ref 00001000311R

Active European Union and United States. Also listed in GUDID (US).

CE IVDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

5 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K060162↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number84269504534828A Basic UDI-DI 08426950453482UDI-DIDate20 Sep 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number08426950453482 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK060162 Date21 Feb 2006IssuedStatusActive

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  • Withdrawn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
  • United States FDA 510(k) Active
  • European Union CE/IVDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
ACL ELITE Pro Refurbished EUDAMED
Acl Elite Pro GUDID
Generic Name
Coagulation analyser IVD, laboratory
Model / Ref / Catalog
00001000311R
Primary DI / UDI-DI
08426950453482
Basic UDI-DI
84269504534828A
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
Austria
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

Other properties (20)

  • 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
  • Manufacturing Date: No