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AutoMate 2500 Family

by Beckman Coulter Inc.

Ref ODL25120, ODL25125, ODL25250, ODL25255Model AutoMate 1200, AutoMate 1250, AutoMate 2500, AutoMate 2550

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

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number150995901ATMJ8 Basic UDI-DI 15099590364106UDI-DIDate13 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590364106 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.

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  • Withdrawn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
AutoMate 1200, AutoMate 1250, AutoMate 2500, AutoMate 2550, ODL25120, ODL25125, ODL25250, ODL25255
Primary DI / UDI-DI
15099590364106
Basic UDI-DI
150995901ATMJ8
FDA Product Code
JQP
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
862.2100
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
AutoMate 1200, AutoMate 1250, AutoMate 2500, AutoMate 2550
ODL25120, ODL25125, ODL25250, ODL25255
GUDID
AutoMate 1250
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

  • Surgical Instrument
  • Premarket Exempt
  • Serial Number
  • Manufacturing Date

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
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Expiration Date: No