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Cell-Dyn 09H46-02

by Abbott Laboratories

Ref 09H4602

Cell-Dyn 09H46-02 (09H4602) is a device classified as Class A in the EU and Class I in the US made by Abbott Laboratories, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 038074EAH0946GW) and listed in FDA GUDID since 6 Jun 2016 (UDI-DI 00380740020132), active as of 23 Oct 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074EAH0946GW Basic UDI-DI 00380740020132UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740020132 UDI-DI Date6 Jun 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074EAH0946GW registered 17 Aug 2026 Active
  • FDA GUDID UDI-DI 00380740020132 listed 6 Jun 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740020132
  2. Registered EUDAMED 038074EAH0946GW

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  • Withdrawn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
Cell-Dyn
Generic name
Buffered wash solution IVD
Model / Ref / Catalog
09H4602, 09H46-02
Primary DI / UDI-DI
00380740020132
Basic UDI-DI
038074EAH0946GW
FDA product code
JCB
EMDN code
W0103010105 Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)
GMDN term
Buffered wash solution IVD
Device class
Class A EUDAMED
Class I GUDID
Regulation number
864.4010
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
09H4602
GUDID
09H46-02
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 wash solution IVD

Similar devices in this category

Other devices filed under CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEATH-FLUIDS).

Other devices from Abbott Laboratories

See all devices from Abbott Laboratories →

Properties

  • Contains substances of microbial origin
  • Reagent
  • Professional testing
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Expiration date
Other properties (18, all answered No)