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Mycoplasma Pneumonia IgM Rapid Test Cassette

by Zhuhai Encode Medical Engineering Co., Ltd. EUDAMED

Active European Union

Ref LMP0120

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974566303056 Basic UDI-DIDate9 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
LMP0120
Primary DI / UDI-DI
06974566303056
Basic UDI-DI
B-06974566303056
EMDN Code
W0105010802 Mycoplasma antibody assays
Device Class
Class IVD General
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000019361
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

Show properties
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No