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X100HT With Full Field Bone Marrow Aspirate (BMA) Application

by Scopio Labs Ltd. EUDAMED

Active European Union

Ref SC-SYS-00008

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-07290118610465 Basic UDI-DIDate10 Jun 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
X100/X100HT With Full Field Bone Marrow Aspirate (BMA) Application
Model / Reference
SC-SYS-00008
Primary DI / UDI-DI
07290118610465
Basic UDI-DI
B-07290118610465, 7290018417SCOPIOlabsBMA2C
Direct Marketing DI
07290118610465
EMDN Code
W02020199 Cell counting instruments - other
Device Class
Class IVD General
Class B
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
IL-MF-000025129
Authorised representative
Obelis s.a. BE-AR-000000106

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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