Skip to content

Oc-Sensor Fit

by Eiken Chemical Co., Ltd.

Ref V-PZ05Model OC-SENSOR Reagent Family

Active European Union

CE IVDR

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4987026TD-OCHBYG Basic UDI-DIDate19 May 2022RegisteredStatusActive

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  • Withdrawn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/IVDR Active

Specification

EUDAMED

Model / Reference
OC-SENSOR Reagent Family, V-PZ05
Primary DI / UDI-DI
04987026369754
Basic UDI-DI
4987026TD-OCHBYG
EMDN Code
W0102039013 Fecal occult blood (ic)
Device Class
Class C
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
JP-MF-000018097
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Eiken Chemical Co., Ltd.

See all devices from Eiken Chemical Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No