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Mycotest

by G. PAPANIKOLAOU & CO. LP - Bioprepare EUDAMED

Active European Union

Ref 100081Model MYCOTEST 100081

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number52120377100081C7 Basic UDI-DIDate2 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

0 certificates · EUDAMED

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

Specification

EUDAMED

Model / Reference
MYCOTEST 100081, 100081
Primary DI / UDI-DI
05212037700173
Basic UDI-DI
52120377100081C7
EMDN Code
W0104080207 Mycoplasma / ureaplasma - (incl. combined id-ast)
Device Class
Class A
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
EL-MF-000055282

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Properties

  • Sterile
  • Reagent
  • Professional Testing

Other properties (8)

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