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Diagnostic Kit for Human IgM Antibody of Mycoplasma Pneumoniae (Immunochromatographic Assay)

by Guangzhou Wondfo Biotech Co., Ltd. 2 variants

Ref W113P0003

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-W113P0003KC Basic UDI-DI D-W113P0003KCUDI-DIDate20 Oct 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  • Withdrawn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
Diagnostic Kit for Human IgM Antibody of Mycoplasma Pneumoniae (Immunochromatographic Assay)
Model / Reference
W113P0003
Primary DI / UDI-DI
D-W113P0003KC
Basic UDI-DI
B-W113P0003KC
EMDN Code
W0105010802 Mycoplasma antibody assays
Device Class
Class IVD General
EU market of registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000000689
Authorised representative
QbD RepS BV BE-AR-000000040

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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