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Mycoplasma Antigen Rapid Test

by Zhejiang Anji Saianfu Biotechnology Co., Ltd. China EUDAMED

Ref 3022202 EMDN W0105010801

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-69743840313390 Basic UDI-DIDate28 Apr 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
3022202
Primary DI / UDI-DI
69743840313390
Basic UDI-DI
B-69743840313390
EMDN Code
W0105010801 Mycoplasma antigen detection
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
CN-MF-000045029
Authorised representative
Lotus NL B.V. NL-AR-000000121

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Near-Patient Testing
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 18073e50-a18e-4fd0-ad5b-345eed65d6b1 61 fields · synced 23 Oct 2026