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NovaLisa® Mycoplasma pneumoniae IgM

by Gold Standard Diagnostics Frankfurt GmbH 2 variants

Ref MYCM0350DS

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-+ENTIMYCM0350DS06 Basic UDI-DI +ENTIMYCM0350DS06UDI-DIDate9 Jul 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Device Name
NovaLisa® Mycoplasma pneumoniae IgM
Model / Reference
MYCM0350DS
Primary DI / UDI-DI
+ENTIMYCM0350DS06
Basic UDI-DI
B-+ENTIMYCM0350DS06
EMDN Code
W0105010802 Mycoplasma antibody assays
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000025020

Other devices from Gold Standard Diagnostics Frankfurt GmbH

See all devices from Gold Standard Diagnostics Frankfurt GmbH →

Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No