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Sample Separation Media

by Cellomics (Shenzhen) Limited 3 variants

Ref CTCP0007

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697982287CTCP0007GF Basic UDI-DI 06979822870174UDI-DIDate31 Mar 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  • Withdrawn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
Sample Separation Media
Model / Reference
CTCP0007
Primary DI / UDI-DI
06979822870174
Basic UDI-DI
697982287CTCP0007GF
EMDN Code
W01030199 Haematology reagents - 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

Other devices from Cellomics (Shenzhen) Limited

See all devices from Cellomics (Shenzhen) Limited →

Properties

  • Reagent

Other properties (10)

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