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Liquid-Based Cytology Reagent and Consumable

by Motic (Xiamen) Medical Diagnostic Systems Co., Ltd China EUDAMED

Ref ASPS 6000, ASPS 6000 Plus, ASPS 9600Model ASPS 9600、ASPS 6000、ASPS 9600 Plus、ASPS 6000 Plus EMDN W01030799

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697896968Liquid-Based7T Basic UDI-DIDate24 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Liquid-Based Cytology Reagent and Consumable
Model / Reference
ASPS 9600、ASPS 6000、ASPS 9600 Plus、ASPS 6000 Plus, ASPS 6000, ASPS 6000 Plus, ASPS 9600
Primary DI / UDI-DI
06978969680059, 06978969680073, 06978969680042
Basic UDI-DI
697896968Liquid-Based7T
EMDN Code
W01030799 Histology / cytology reagents - other
Device Class
Class A
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000052629
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

Other devices from Motic (Xiamen) Medical Diagnostic Systems Co., Ltd

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (3)

  • EUDAMED 8a9ae474-af01-4f29-a6e4-bd101f7f9d36 61 fields · synced 22 Oct 2026
  • EUDAMED 06978969680073|697896968LIQUID-BASED7T 61 fields · synced 17 May 2026
  • EUDAMED 06978969680042|697896968LIQUID-BASED7T 61 fields · synced 18 May 2026