Stromatolyser-4DS

by Sysmex Corporation Japan EUDAMED

Ref 984-1721-6

EMDN W0103010103

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number4987562STROMATOLYSER4DSCS Basic UDI-DI	Date22 Jun 2023Registered	StatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

Withdrawn
Not covered

European Union — CE/IVDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference: 984-1721-6

Primary DI / UDI-DI: 14987562509093
Basic UDI-DI: 4987562STROMATOLYSER4DSCS
EMDN Code: W0103010103 Complete cell count

Device Class: Class A
Market of Registration: Germany

Manufacturer details

EUDAMED SRN: JP-MF-000014037
Authorised representative: Sysmex Europe SE DE-AR-000022333

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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 (1)

EUDAMED 62a76c74-0871-4c51-9a5f-ff63bf51f421 61 fields · synced 25 Oct 2026