Skip to content

Synchron 471080

by Beckman Coulter, Inc.

Ref 471080

Synchron 471080 is a multiple-therapy therapeutic drug monitoring IVD (EU IVDD general IVD; FDA Class II; FDA product code DKB, Calibrators, Drug Mixture) made by Beckman Coulter, Inc., registered in EUDAMED on 10 Jun 2022 (Basic UDI-DI B-471080PP) and listed in FDA GUDID since 24 Aug 2016 (UDI-DI D-471080PP), active as of 23 Oct 2026.

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

CE IVDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-471080PP Basic UDI-DI D-471080PPUDI-DIDate10 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-471080PP UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-471080PP registered 10 Jun 2022 Active
  • FDA GUDID UDI-DI D-471080PP listed 24 Aug 2016 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID D-471080PP
  2. Registered EUDAMED B-471080PP

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
SYNCHRON Systems Drug Calibrator 3 Plus EUDAMED
Synchron GUDID
Generic name
Multiple-therapy therapeutic drug monitoring IVD, calibrator
Model / Ref / Catalog
471080
Primary DI / UDI-DI
D-471080PP EUDAMED
15099590222222 GUDID
Basic UDI-DI
B-471080PP
FDA product code
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
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-471080PP
GUDID
15099590222222
Device classEUDAMED
Class IVD General
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-471080PP; FDA GUDID lists 15099590222222), so their flags are not compared. Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Multiple-therapy therapeutic drug monitoring IVD, calibrator

Similar devices in this category

Other devices filed under TDM/DRUG STANDARDS AND CALIBRATORS.

Other devices from Beckman Coulter, Inc.

See all devices from Beckman Coulter, Inc. →

Properties

  • Single use
  • Contains human tissues or cells
  • Reagent
  • Professional testing
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (16, all answered No)