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Refill solution

by Shenzhen Cornley Bio-Medical Co., Ltd. China EUDAMED

Ref /Model FS01,FS02,FS03,FS04

EMDN W0101060606,W01019099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697287382FS12PC Basic UDI-DIDate23 May 2026RegisteredStatusActive

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
FS01, FS02, FS03, FS04, /
Primary DI / UDI-DI
06972873820969
Basic UDI-DI
697287382FS12PC
Direct Marketing DI
06972873820969
EMDN Code
W0101060606,W01019099
Device Class
Class A

Manufacturer details

EUDAMED SRN
CN-MF-000017322
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from Shenzhen Cornley Bio-Medical Co., Ltd.

See all devices from Shenzhen Cornley Bio-Medical Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
Other properties (10)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 54265a4a-7f27-4feb-8fd8-60a21db87eaa 61 fields · synced 22 Oct 2026