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SYNCHRON Systems Drug Calibrator 1

by Beckman Coulter Inc. United States EUDAMED510(k)GUDID

Ref 469600, 469630 Product code DLJEMDN W0102152201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-469600RA Basic UDI-DIDate10 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-469600RA UDI-DIDate24 Aug 2016ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK993473 Date26 Nov 1999IssuedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/IVDD Expiring

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 23 Oct 2026

Trade Name
SYNCHRON Systems Drug Calibrator 1 EUDAMED
SYNCHRON Systems Drug Calibrator 2 EUDAMED
Synchron GUDID
Generic Name
Multiple-therapy therapeutic drug monitoring IVD, calibrator
Model / Ref / Catalog
469600, 469630
Primary DI / UDI-DI
D-469600RA EUDAMED
D-469630RK EUDAMED
15099590200039 GUDID
15099590200046 GUDID
Basic UDI-DI
B-469600RA, B-469630RK
FDA Product Code
DLJ, DKB
EMDN Code
W0102152201 Tdm/drug standards and calibrators
GMDN Term
Multiple-therapy therapeutic drug monitoring IVD, calibrator
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
862.3200
Market of Registration
Ireland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-469600RA
D-469630RK
GUDID
15099590200039
15099590200046
Device ClassEUDAMED
Class IVD General
GUDID
Class II

Manufacturer details

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

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Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Human Tissues NoEUDAMEDYesEUDAMED
  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (13)
  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (5)

  • EUDAMED 1845ea72-b315-4bd1-a224-d1caa34e5316 61 fields · synced 23 Oct 2026
  • FDA UDI 6d1e60a6-c815-4cd3-8261-71f7d8510c82 34 fields · synced 30 May 2026
  • FDA UDI ca9e629c-8a6b-4410-a0b8-af2d70a81047 34 fields · synced 30 May 2026
  • EUDAMED D-469630RK|B-469630RK 61 fields · synced 14 Jul 2026
  • FDA 510(k) K993473 1 fields · synced 18 May 2026