Skip to content

BLX Liquid-based Cytology Test Slide Processor

by Tianjin Bai Lixin Bio-tech Co., Ltd. EUDAMED

Active European Union

Ref In-SP630IIModel BCT-630II

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697498683InSP630IITG Basic UDI-DIDate27 Nov 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  • Withdrawn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

Model / Reference
BCT-630II, In-SP630II
Primary DI / UDI-DI
06974986838053
Basic UDI-DI
697498683InSP630IITG
Direct Marketing DI
06974986838053
EMDN Code
W0202059002,W0202059099,W02060199
Device Class
Class A
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000040961
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

Other devices from Tianjin Bai Lixin Bio-tech Co., Ltd.

See all devices from Tianjin Bai Lixin Bio-tech Co., Ltd. →

Properties

Show 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