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Immunofluorescence Analyzer

by Shenzhen Superbio Technology Co., Ltd. China EUDAMED

Ref SUPE01105Model EASY-11

EMDN W0201069099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697452100SUPE011TN Basic UDI-DIDate18 Apr 2023RegisteredStatusActive

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
EASY-11, SUPE01105
Primary DI / UDI-DI
06974521000068
Basic UDI-DI
697452100SUPE011TN
Direct Marketing DI
06974521000068
EMDN Code
W0201069099 Various rapid test chemistry / immunochemistry instruments - other
Device Class
Class A
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000024149
Authorised representative
QbD RepS BV BE-AR-000000040

Other devices from Shenzhen Superbio Technology Co., Ltd.

See all devices from Shenzhen Superbio Technology 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 (1)

  • EUDAMED 6beb7e71-a492-4718-b65b-a53ad2d77617 61 fields · synced 22 Oct 2026