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X100 With Full Field Peripheral Blood Smear (PBS) Application

by Scopio Labs Ltd. EUDAMED510(k)GUDID

Active European Union and United States

Ref SC-SYS-00001510(k) K243144

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED Number7290018417SCOPIOlab2015FG Basic UDI-DIDate21 Dec 2025RegisteredStatusActive
European UnionCE/IVDR EUDAMED Number7290018417SCOPIOlab2015FG Basic UDI-DIDate21 Dec 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK243144 Date27 Jun 2025ClearedStatusActive
United StatesGUDID listing GUDID Number07290018417133 UDI-DIDate30 Dec 2022ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceAustriaHungaryRomaniaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaFranceFranceSloveniaBulgariaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaPortugalSpainSpainItalyUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSpainSpainCroatiaGreeceUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaMaltaCyprusUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/IVDD, CE/IVDR Active
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID

Trade Name
X100 With Full Field Peripheral Blood Smear (PBS) Application EUDAMED
X100 with Full Field Peripheral Blood Smear Application GUDID
Generic Name
Cell morphology analyser IVD, automated/semi-automated
Device Name
X100/X100HT With Full Field Peripheral Blood Smear (PBS) Application
Model / Reference
SC-SYS-00001
Description
X100 with Processing Unit and FF-PBS application. Includes: - X100 Scanner - X100 Processing Unit - X100 User Maintenance Kit
Primary DI / UDI-DI
07290018417133
Basic UDI-DI
7290018417SCOPIOlab2015FG, B-07290018417133
Direct Marketing DI
07290018417133
510(k) Number
FDA Product Code
JOY
EMDN Code
W02020199 Cell counting instruments - other
GMDN Term
Cell morphology analyser IVD, automated/semi-automated
Device Class
Class B EUDAMED
Class IVD General EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 864.5260
Market of Registration
Austria
Belgium
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class B
Class IVD General
510(k)
Class II
GUDID
Class II

Manufacturer details

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

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Properties

  • Professional Testing
  • Surgical Instrument
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No