Skip to content

Fully Automated IHC & ISH Staining System

by Guangzhou LBP Medicine Science & Technology Co., Ltd. EUDAMED

Active European Union

Ref 198-242V：CCP.000145-2Model Hyper S9 Hyper S5 ( 99-121V) Hyper S5 ( 198-242V)

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69485009IHC001KL Basic UDI-DIDate18 Dec 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Fully Automated IHC & ISH Staining System
Model / Reference
Hyper S9 Hyper S5 ( 99-121V) Hyper S5 ( 198-242V), 198-242V：CCP.000145-2
Primary DI / UDI-DI
06948500937560
Basic UDI-DI
69485009IHC001KL
EMDN Code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000026786
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Guangzhou LBP Medicine Science & Technology Co., Ltd.

See all devices from Guangzhou LBP Medicine Science & Technology Co., Ltd. →

Properties

  • Professional Testing
  • Surgical Instrument
  • New Device

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No