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Full Range C-Reactive Protein (FR-CRP) Assay Kit (Latex-enhanced Immunonephelometry)

by Shenzhen CoooSeee Biomedical Co., Ltd. 4 variants

Ref 1640E-PA00002Model CH8600CS CH8601CS CH8602CS

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 linked in EUDAMED

A group certificate may exist

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 Number697806677CH002HV Basic UDI-DI 06978066778420UDI-DIDate22 Aug 2026RegisteredStatusActive EUDAMED: not on the EU market

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.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Automatic Hematology Analyzer
Model / Reference
CH8600CS CH8601CS CH8602CS, 1640E-PA00002
Primary DI / UDI-DI
06978066778420
Basic UDI-DI
697806677CH002HV
EMDN Code
W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)
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.

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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