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Uc Control AU448468

by Sysmex Corporation

Ref AU-448-468

Uc Control AU448468 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-04987562433469), cleared under FDA 510(k) K081908 on 16 Jan 2009 and listed in FDA GUDID since 30 Nov 2022 (UDI-DI 04987562433469), active as of 12 Nov 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 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K081908

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-04987562433469 Basic UDI-DI 04987562433469UDI-DIDate7 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04987562433469 UDI-DI Date30 Nov 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK081908 Date16 Jan 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-04987562433469 registered 7 Oct 2026 Active
  • FDA 510(k) K081908 decided 16 Jan 2009 Active
  • FDA GUDID UDI-DI 04987562433469 listed 30 Nov 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K081908
  2. Listed FDA GUDID 04987562433469
  3. Registered EUDAMED B-04987562433469

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  • Withdrawn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
Uc-Control EUDAMED
Uc Control GUDID
Generic name
Buffered sample diluent IVD
Model / reference
AU-448-468 EUDAMED
AU448468 GUDID
Primary DI / UDI-DI
04987562433469
Basic UDI-DI
B-04987562433469
510(k) Number
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 — 10 Milliliter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AU-448-468
GUDID
AU448468
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

Cleared under the same submission (K081908)

Similar devices in this category

Other devices filed under URINE TESTING CONTROLS.

Other devices from Sysmex Corporation

See all devices from Sysmex Corporation →

Properties

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