NS96 Kit (SH)

by Shimadzu Chemistry and Diagnostics France EUDAMED

Ref S227-49503-55 EMDN W0103010299

Regulatory status

as of 25 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/IVDR	Number3770024008NEOSICKLEBW Basic UDI-DI	Date3 Jun 2026Registered	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name: NeoSickle
Model / Reference: S227-49503-55

Primary DI / UDI-DI: 03770024008036
Basic UDI-DI: 3770024008NEOSICKLEBW
EMDN Code: W0103010299 Other haemoglobin (types) testing - other

Device Class: Class C
Market of Registration: France

Manufacturer details

EUDAMED SRN: FR-MF-000048960

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Pack 1000

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Control Set

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System Cleaning Phase

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Column Set

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Properties & raw data

Show properties, registry sources and raw records

Human Tissues
Reagent
Professional Testing

Other properties (8)

Sterile: 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 4955a1e7-1cc9-4468-b938-4677b089550d 61 fields · synced 24 Oct 2026