Skip to content

CellSolutions

by CellSolutions LLC United States EUDAMED

Ref CS-BCDIAS

EMDN W02029092

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00852468008339 Basic UDI-DIDate16 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
BestCyte Digital Image Analysis Software
Model / Reference
CS-BCDIAS
Primary DI / UDI-DI
00852468008339
Basic UDI-DI
B-00852468008339
EMDN Code
W02029092 Various hematology / histology / cytology instruments - IVD medical device software
Device Class
Class IVD General
Special Device Type
-1202
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000029202
Authorised representative
CellSolutions GmbH DE-AR-000017179

Other devices from CellSolutions LLC

See all devices from CellSolutions LLC →

Properties & raw data

Show properties, registry sources and raw records
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 99783f94-c86c-4888-977e-800c56d73281 61 fields · synced 23 Oct 2026