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Automated Slide Preparation and Staining System

by BotuAImaging Technology Co., Ltd. EUDAMED

Active European Union

Ref 004Model BP-K

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697626387SH004N5 Basic UDI-DIDate30 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

Model / Reference
BP-K, 004
Primary DI / UDI-DI
06976263872040
Basic UDI-DI
697626387SH004N5
Direct Marketing DI
06976263872040
EMDN Code
W0202059002 Automated slide stainers
Device Class
Class A
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
CN-MF-000035048
Authorised representative
Kingsmead Service B.V. NL-AR-000002066

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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