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Cell-Dyn 08H67-01

by Abbott Laboratories

Ref 08H6701

Cell-Dyn 08H67-01 (08H6701) is a device classified as Class B in the EU and Class II in the US made by Abbott Laboratories, registered in EUDAMED on 22 Oct 2026 (Basic UDI-DI 038074RUH0867Y2) and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00380740017170), active as of 7 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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR EUDAMED Number038074RUH0867Y2 Basic UDI-DI 00380740017170UDI-DIDate22 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00380740017170 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 038074RUH0867Y2 registered 22 Oct 2026 Active
  • FDA GUDID UDI-DI 00380740017170 listed 9 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00380740017170
  2. Registered EUDAMED 038074RUH0867Y2

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  • Withdrawn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
Haematological cell analyser IVD
Model / Ref / Catalog
08H6701, 08H67-01
Primary DI / UDI-DI
00380740017170
Basic UDI-DI
038074RUH0867Y2
FDA product code
GKZ
EMDN code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
GMDN term
Haematological cell analyser IVD
Device class
Class B EUDAMED
Class II GUDID
Regulation number
864.5220
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
08H6701
GUDID
08H67-01
Device classEUDAMED
Class B
GUDID
Class II

Device class is stated on each registry's own scale: Class B in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Haematological cell analyser IVD

Similar devices in this category

Other devices filed under AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr).

Other devices from Abbott Laboratories

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Properties

  • Contains latex
  • Professional testing
  • IVD instrument
  • Prescription use
  • Serial number
Other properties (21, all answered No)