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Real-Time PCR System

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

Ref FZ-100, FZ-3840, FZ-960

EMDN W02050201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69511109FZ-100BJ 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 22 Oct 2026

Model / Reference
FZ-100, FZ-3840, FZ-960
Primary DI / UDI-DI
06951110910274, 06951110938414, 06951110996117
Basic UDI-DI
69511109FZ-100BJ, 69511109FZ-38408L, 69511109FZ-960DC
Direct Marketing DI
06951110910274
06951110938414
06951110996117
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

Other devices from Shenzhen Everbest Machinery lndustry Co., Ltd.

See all devices from Shenzhen Everbest Machinery lndustry Co., Ltd. →

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 (3)

  • EUDAMED 7d88319c-f77f-4924-a385-772129d2867f 61 fields · synced 22 Oct 2026
  • EUDAMED 06951110938414|69511109FZ-38408L 61 fields · synced 17 May 2026
  • EUDAMED 06951110996117|69511109FZ-960DC 61 fields · synced 18 May 2026