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SimplexTAS Chemistry Control Level 2

by tascom co., ltd. EUDAMED

Active European Union

Ref T0301002

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08800037901231 Basic UDI-DIDate13 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Device Name
SimplexTAS Chemistry Control Level 2
Model / Reference
T0301002
Primary DI / UDI-DI
08800037901231
Basic UDI-DI
B-08800037901231
EMDN Code
W0101050102 Unassayed multicomponent controls (cc)
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
KR-MF-000019000
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

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Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No