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Fully Automated IHC & ISH Staining System

by Guangzhou LBP Medicine Science & Technology Co., Ltd. 3 variants

Ref 99-121V：06948500938987Model Hyper S9 Hyper S5 ( 99-121V) Hyper S5 ( 198-242V)

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, self-declared

Class I: no certifier involved

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 Number69485009IHC001KL Basic UDI-DI 06948500938987UDI-DIDate18 Dec 2024RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Fully Automated IHC & ISH Staining System
Model / Reference
Hyper S9 Hyper S5 ( 99-121V) Hyper S5 ( 198-242V), 99-121V：06948500938987
Primary DI / UDI-DI
06948500938987
Basic UDI-DI
69485009IHC001KL
EMDN Code
W02060101 Automated systems for the management of pre and post-analysis
Device Class
Class A
EU market of registration
Netherlands

Manufacturer details

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

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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