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OGCare Control Solution

by Biochemical Systems International S.p.A. Italy EUDAMED

Ref 3880300Model OGCare Control Solution EMDN W010106010801

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08032937231112 Basic UDI-DIDate6 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
OGCare Control Solution - ITA / ENG
Model / Reference
OGCare Control Solution, 3880300
Primary DI / UDI-DI
08032937231112
Basic UDI-DI
B-08032937231112
EMDN Code
W010106010801 Blood test strips controls
Device Class
Class IVD Annex II List B
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IT-MF-000028905

Other devices from Biochemical Systems International S.p.A.

See all devices from Biochemical Systems International S.p.A. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 07ad70d1-289b-4b9f-bccf-a1971bee7d53 61 fields · synced 22 Oct 2026