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Flow Cytometer

by Beijing Challen Biotechnology Co., Ltd. 64 variants

Ref C.LS.A5106EModel Cytosteller DX05

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697530920035JN Basic UDI-DI 06975309200359UDI-DIDate12 Feb 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Flow Cytometer
Model / Reference
Cytosteller DX05, C.LS.A5106E
Primary DI / UDI-DI
06975309200359
Basic UDI-DI
697530920035JN
Direct Marketing DI
06975309200359
EMDN Code
W0202040103 Cytoflowmeters - high routine
Device Class
Class A
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000023656
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Beijing Challen Biotechnology Co., Ltd.

See all devices from Beijing Challen Biotechnology Co., Ltd. →

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No