Skip to content

Cellpack Dst Dst-300A

by Sysmex Corporation

Ref DST-300A

Cellpack Dst Dst-300A is a device classified as Class A in the EU and Class I in the US made by Sysmex Corporation, registered in EUDAMED on 23 Aug 2023 (Basic UDI-DI 4987562CELLPACKDSTZ9) and listed in FDA GUDID since 4 Nov 2022 (UDI-DI 00664369000264), active as of 12 Nov 2026.

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

CE IVDR

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 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number4987562CELLPACKDSTZ9 Basic UDI-DI 00664369000264UDI-DIDate23 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00664369000264 UDI-DI Date4 Nov 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 4987562CELLPACKDSTZ9 registered 23 Aug 2023 Active
  • FDA GUDID UDI-DI 00664369000264 listed 4 Nov 2022 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 00664369000264
  2. Registered EUDAMED 4987562CELLPACKDSTZ9

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Cellpack Dst
Generic name
Buffered sample diluent IVD
Model / reference
DST-300A
Primary DI / UDI-DI
00664369000264
Basic UDI-DI
4987562CELLPACKDSTZ9
FDA product code
GIF
EMDN code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
GMDN term
Buffered sample diluent IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.8200
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 20 Liter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class A
GUDID
Class I

Device class is stated on each registry's own scale: Class A 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 CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS).

Other devices from Sysmex Corporation

See all devices from Sysmex Corporation →

Properties

  • Single use
  • Reagent
  • Professional testing
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)