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Uf-Control BE740265

by Sysmex Corporation

Ref BE-740-265

Uf-Control BE740265 is a device classified as IVD General (EU), Class I (US) made by Sysmex Corporation, registered in EUDAMED on 7 Oct 2026 (Basic UDI-DI B-04987562433681) and listed in FDA GUDID since 30 Nov 2022 (UDI-DI 04987562433681), active as of 12 Nov 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-04987562433681 Basic UDI-DI 04987562433681UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04987562433681 UDI-DI Date30 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04987562433681 registered 7 Oct 2026 Active
  • FDA GUDID UDI-DI 04987562433681 listed 30 Nov 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04987562433681
  2. Registered EUDAMED B-04987562433681

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  • Withdrawn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
Uf-Control
Generic name
Buffered sample diluent IVD
Model / reference
BE-740-265 EUDAMED
BE740265 GUDID
Primary DI / UDI-DI
04987562433681
Basic UDI-DI
B-04987562433681
FDA product code
JJW
EMDN code
W010106020601 Urine testing controls
GMDN term
Buffered sample diluent IVD
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
Germany
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 30 Milliliter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
BE-740-265
GUDID
BE740265
Device classEUDAMED
Class IVD General
GUDID
Class I

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: Buffered sample diluent IVD

Similar devices in this category

Other devices filed under URINE TESTING CONTROLS.

Other devices from Sysmex Corporation

See all devices from Sysmex Corporation →

Properties

  • Reagent
  • IVD kit
  • Professional testing
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (18, all answered No)