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Mycoplasma IgM Rapid Test

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

Ref 3022201, Cassette

EMDN W0105010802

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-69743840312546 Basic UDI-DIDate28 Apr 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Withdrawn
  • Not covered

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
3022201, Cassette
Primary DI / UDI-DI
69743840312546, D-MycoplasmaIgMLE
Basic UDI-DI
B-69743840312546, B-MycoplasmaIgMLE
EMDN Code
W0105010802 Mycoplasma antibody assays
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

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

Other devices from Zhejiang Anji Saianfu Biotechnology Co., Ltd.

See all devices from Zhejiang Anji Saianfu Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Reagent NoEUDAMEDYesEUDAMED
  • Near-Patient Testing YesEUDAMEDNoEUDAMED
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (2)

  • EUDAMED 7b48ca0a-37ff-4cb3-9ac2-4bee872ce633 61 fields · synced 23 Oct 2026
  • EUDAMED D-MYCOPLASMAIGMLE|B-MYCOPLASMAIGMLE 61 fields · synced 18 Sep 2026