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X100HT With Full Field Peripheral Blood Smear (PBS) Application

by Scopio Labs Ltd.

Ref SC-SYS-00002

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-07290018417140 Basic UDI-DI 07290018417140UDI-DIDate10 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number07290018417140 UDI-DI Date30 Dec 2022ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · 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-00002
Description
X100HT with Processing Unit and FF-PBS application. Includes: - X100HT Scanner - X100HT Processing Unit - X100HT User Maintenance Kit
Primary DI / UDI-DI
07290018417140
Basic UDI-DI
B-07290018417140, 7290018417SCOPIOlab2015FG
Direct Marketing DI
07290018417140
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 IVD General EUDAMED
Class B EUDAMED
Class II GUDID
Regulation Number
864.5260
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IVD General
Class B
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