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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 1366E-PA00001Model CH8300CRP CH8301CRP CH8302CRP CH8300 CH8301 CH8302 CH8310 CH8311 CH8312

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697806677CH005J3 Basic UDI-DI 06978066778239UDI-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  • Withdrawn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
CH8300CRP CH8301CRP CH8302CRP CH8300 CH8301 CH8302 CH8310 CH8311 CH8312, 1366E-PA00001
Primary DI / UDI-DI
06978066778239
Basic UDI-DI
697806677CH005J3
EMDN Code
W0202010201 Automated 3 part hematology analysers
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