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Mycoplasma Pneumoniae Detection Kit (Fluorescence PCR)

by Zhejiang Orient Gene Biotech Co., Ltd EUDAMED

Active European Union

Ref AMP01-AOG48E; AMP01-AOG96E; AMP01D-AOG48E; AMP01D-AOG96E

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-69509960AMP01RKTR Basic UDI-DIDate25 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Mycoplasma Pneumoniae Detection Kit (Fluorescence PCR)
Model / Reference
AMP01-AOG48E, AMP01-AOG96E, AMP01D-AOG48E, AMP01D-AOG96E
Primary DI / UDI-DI
D-69509960AMP01RKTR
Basic UDI-DI
B-69509960AMP01RKTR
EMDN Code
W010501080301 Mycoplasma pneumoniae detection by na reagents
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000017965
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhejiang Orient Gene Biotech Co., Ltd.

See all devices from Zhejiang Orient Gene Biotech Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No