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GENEYE® Mycoplasma Pneumoniae Assay

by Suzhou GenDx Biotech Co., Ltd. EUDAMED

Active European Union

Ref RP003

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975102280190 Basic UDI-DIDate27 Apr 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  • Withdrawn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

Device Name
GENEYE® Mycoplasma Pneumoniae Assay
Model / Reference
RP003
Primary DI / UDI-DI
06975102280190
Basic UDI-DI
B-06975102280190
EMDN Code
W010501080301 Mycoplasma pneumoniae detection by na reagents
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000018830
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Suzhou GenDx Biotech Co., Ltd.

Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No