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Synchron 474991

by Beckman Coulter, Inc.

Ref 474991

Synchron 474991 is a device classified as IVD General (EU), Class I (US) made by Beckman Coulter, Inc., registered in EUDAMED on 10 Jun 2022 (Basic UDI-DI B-474991RW), cleared under FDA 510(k) K993023 on 26 Nov 1999 and listed in FDA GUDID since 24 Aug 2016 (UDI-DI D-474991RW), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE IVDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K993023

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-474991RW Basic UDI-DI D-474991RWUDI-DIDate10 Jun 2022RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-474991RW UDI-DI Date24 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK993023 Date26 Nov 1999DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-474991RW registered 10 Jun 2022 Active
  • FDA 510(k) K993023 decided 26 Nov 1999 Active
  • FDA GUDID UDI-DI D-474991RW 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

3 dated events

  1. Cleared FDA 510(k) K993023
  2. Listed FDA GUDID D-474991RW
  3. Registered EUDAMED B-474991RW

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
SYNCHRON Systems OP 300 High Urine Control EUDAMED
Synchron GUDID
Generic name
Opiate/opiate metabolite IVD, control
Model / Ref / Catalog
474991
Primary DI / UDI-DI
D-474991RW EUDAMED
15099590221997 GUDID
Basic UDI-DI
B-474991RW
510(k) Number
FDA product code
JJY
EMDN code
W0102152009 Controls for narcotics / toxicology
GMDN term
Opiate/opiate metabolite IVD, control
Device class
Class IVD General EUDAMED
Class I GUDID
Regulation number
862.1660
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-474991RW
GUDID
15099590221997
Device classEUDAMED
Class IVD General
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists D-474991RW; FDA GUDID lists 15099590221997), so their flags are not compared. Device class is stated on each registry's own scale: Class IVD General in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Opiate/opiate metabolite IVD, control

Similar devices in this category

Other devices filed under CONTROLS FOR NARCOTICS / TOXICOLOGY.

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
Other properties (17, all answered No)