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Digital Slide Scanner for Pathology

by Suzhou Betrue Technology Co., Ltd. EUDAMED

Active European Union

Ref IBL FP40Model IBL 200, IBL 400, IBL 700, IBL 006F, IBL 030F, IBL 060F, IBL 240F, IBL 480F, BL-006, BL-020, BL-040, BL-060, BL-200, BL-300, BL-400, BL-600, FL-006, FL-020, FL-040, FL-060, FL-200, FL-300, FL-400, FL-600

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697576742IBL0001RR Basic UDI-DIDate3 Jun 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  • Withdrawn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

Device Name
Digital Slide Scanner for Pathology
Model / Reference
IBL 200, IBL 400, IBL 700, IBL 006F, IBL 030F, IBL 060F, IBL 240F, IBL 480F, BL-006, BL-020, BL-040, BL-060, BL-200, BL-300, BL-400, BL-600, FL-006, FL-020, FL-040, FL-060, FL-200, FL-300, FL-400, FL-600, IBL FP40
Primary DI / UDI-DI
06975767420047
Basic UDI-DI
697576742IBL0001RR
EMDN Code
W0202059099 Various processing instruments for hystology / cytology - other
Device Class
Class A
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000039348
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