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Mycoplasma pneumoniae and Chlamydia pneumoniae nucleic acid detection kit (Real-time fluorescence PCR method)

by Guangzhou Deaou Gene Technology Co., Ltd EUDAMED

Active European Union

Model 4 tests/kitRef 8 tests/kit

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06976055490063 Basic UDI-DIDate25 Jan 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Mycoplasma pneumoniae and Chlamydia pneumoniae nucleic acid detection kit (Real-time fluorescence PCR method)
Model / Reference
4 tests/kit, 8 tests/kit
Primary DI / UDI-DI
06976055490063, 06976055490056
Basic UDI-DI
B-06976055490063, B-06976055490056
EMDN Code
W0105010803, W0105099099
Device Class
Class IVD General
Market of Registration
Spain
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000033028
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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Properties

  • Reagent
  • Professional Testing YesEUDAMEDNoEUDAMED

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