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HbA1c Advanced

by Beckman Coulter Inc.

Ref B93009

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number150995901B93009RT Basic UDI-DI 15099590012120UDI-DIDate11 Jan 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number15099590012120 UDI-DI Date13 Feb 2019ListedStatusListed 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  • Withdrawn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

Trade Name
HbA1c Advanced EUDAMED
Au GUDID
Generic Name
Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
Model / Reference
B93009
Primary DI / UDI-DI
15099590012120
Basic UDI-DI
150995901B93009RT
FDA Product Code
PDJ, LCP
EMDN Code
W0102019099 Specific proteins - other
GMDN Term
Glycated haemoglobin (HbA1c) IVD, kit, nephelometry/turbidimetry
Device Class
Class C EUDAMED
Class II GUDID
Regulation Number
862.1373, 864.7470
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class C
GUDID
Class II

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

  • Single Use
  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No