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Power Link

by Beckman Coulter Inc.

Ref B05033Model Power Link

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

1 ongoing

Recall on shared 510(k) K110413; 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 Number150995901PLUQ Basic UDI-DI 15099590583996UDI-DIDate12 Oct 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590583996 UDI-DI Date15 Aug 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

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0117-2022 FDA Class II initiated 28 Jul 2021 on shared 510(k) K110413

    Missing splash guard which may expose users to hazardous materials. .

    • Terminated Z-0046-2018 FDA Class II initiated 3 Aug 2017

    Beckman Coulter has identified that due to a PLC software nonconformity the 1K Stockyard can initiate a retrieval of a sample tube during the rack loading process, which should not occur. This issue and associated complaint were discovered and filed internally.

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  • Withdrawn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
Specimen processing instrument IVD
Model / Ref / Catalog
Power Link, B05033
Primary DI / UDI-DI
15099590583996
Basic UDI-DI
150995901PLUQ
510(k) Number
FDA Product Code
JJE
EMDN Code
W02060101 Automated systems for the management of pre and post-analysis
GMDN Term
Specimen processing instrument IVD
Device Class
Class A EUDAMED
Class I GUDID
Regulation Number
862.2160
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class A
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000010288
Authorised representative
Beckman Coulter Ireland Inc. IE-AR-000000886

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

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