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Hematology Calibrator

by Shenzhen CoooSeee Biomedical Co., Ltd. EUDAMED 3 variants

Active European Union EUDAMED: not on the EU market

Ref 6530-PA00002Model CH-CAL

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697806677HE001JV Basic UDI-DIDate23 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Model / Reference
CH-CAL, 6530-PA00002
Primary DI / UDI-DI
06978066777065
Basic UDI-DI
697806677HE001JV
EMDN Code
W0103010507 Whole blood calibrators
Device Class
Class B

Manufacturer details

EUDAMED SRN
CN-MF-000045646
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shenzhen CoooSeee Biomedical Co., Ltd.

See all devices from Shenzhen CoooSeee Biomedical Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

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