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Standard Infusion Test Kit

by Sophysa

Ref INF-100

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number376012413INF000VE Basic UDI-DI 03760124139556UDI-DIDate7 Oct 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Kit Standard Pour Test De Perfusion
Model / Reference
INF-100
Primary DI / UDI-DI
03760124139556
Basic UDI-DI
376012413INF000VE
EMDN Code
A03040199 Infusion kits (with or w/o pump), single-use - other
Device Class
Class III
Medical Purpose
The Infusion Test Kit is meant to assess the Cerebrospinal Fluid (CSF) hydrodynamics of adult patients, in association with the HydroScreen® Monitor, whenever there is: – a suspected Normal Pressure Hydrocephalus (NPH), after: – a complete clinical examination, to check the presence of the NPH main clinical signs: gait disturbance, a cognitive decline, and urinary incontinence. – a structural and functional neuroimaging to confirm ventriculomegaly. – a lumbar puncture procedure.

Manufacturer details

EUDAMED SRN
FR-PR-000038440

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Properties

  • Sterile