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Real-Time PCR System

by Shenzhen Everbest Machinery lndustry Co., Ltd. China EUDAMED

Ref FZ-80

EMDN W02050201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69511109FZ-80GD Basic UDI-DIDate17 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
FZ-80
Primary DI / UDI-DI
06951110980253
Basic UDI-DI
69511109FZ-80GD
Direct Marketing DI
06951110980253
EMDN Code
W02050201 Micro-array analysers
Device Class
Class A
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000008730
Authorised representative
Lotus NL B.V. NL-AR-000000121

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (1)

  • EUDAMED b24571e4-5f15-4640-9fbf-6b4c99b7bfa6 61 fields · synced 23 Oct 2026