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Refill Solution

by Shenzhen Cornley Bio-Medical Co., Ltd. 4 variants

Ref /Model ISE Ⅰ,ISEⅡ, FS01,FS02,FS03,FS04

Active European Union

CE IVDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697287382ISEWU Basic UDI-DI Date26 Jul 2025RegisteredStatusActive EUDAMED: not on the EU market

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
ISE Ⅰ, ISEⅡ, /, FS01, FS02, FS03, FS04
Primary DI / UDI-DI
06972873821515, 06972873827784, 06972873820952
Basic UDI-DI
697287382ISEWU, 697287382FS12PC
Direct Marketing DI
06972873821515
06972873827784
06972873820952
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.

Properties

  • 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