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BioSci 50

by Biosci Healthcare

Ref SAAModel BioSci 50

Withdrawn No longer placed on the EU market

Was authorized under CE IVDR, withdrawn

Ended

Withdrawn

Date not published (CE IVDR)

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/IVDR Number8909085BIOSCI-SACASK Basic UDI-DIDate6 Aug 2026RegisteredStatusWithdrawn No longer placed on the EU market

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Withdrawn

Specification

EUDAMED

Device Name
Semi-Automated Clinical Chemistry Analyzer (BioSci 50)
Model / Reference
BioSci 50, SAA
Primary DI / UDI-DI
08909085000467
Basic UDI-DI
8909085BIOSCI-SACASK
Direct Marketing DI
08909085000467
EMDN Code
W02010199 Chemistry instruments - other
Device Class
Class A

Manufacturer details

EUDAMED SRN
IN-MF-000052082
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Properties

  • Professional Testing
  • Surgical Instrument

Other properties (9)

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