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HuayueKeju

by Guangzhou Huayue Keju Biotech Co., Ltd. EUDAMED 38 variants

Active European Union

Ref 500ml/bottleModel 2 bottles/box： 450ml / bottle, 500ml /bottle.

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697811548HYKJ004ZP Basic UDI-DIDate11 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Sample density separation solution
Model / Reference
2 bottles/box： 450ml / bottle, 500ml /bottle., 500ml/bottle
Primary DI / UDI-DI
06978115480250
Basic UDI-DI
697811548HYKJ004ZP
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000057705
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Guangzhou Huayue Keju Biotech Co., Ltd.

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Properties

  • Reagent
  • Professional Testing

Other properties (9)

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