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Cell Medical Imaging Analysis System

by Cellomics (Shenzhen) Limited

Ref CVPCP0001Model CellViewer100 Pro

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 Number697982287CVPCP00016K Basic UDI-DI 06979822870471UDI-DIDate2 Sep 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  • Withdrawn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
Cell Medical Imaging Analysis System
Model / Reference
CellViewer100 Pro, CVPCP0001
Primary DI / UDI-DI
06979822870471
Basic UDI-DI
697982287CVPCP00016K
EMDN Code
W02020199 Cell counting instruments - other
Device Class
Class A
EU market of registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000028334
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

  • Surgical Instrument

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
  • New Device: No