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Electrolyte Analyzer

by Shenzhen Cornley Bio-Medical Co., Ltd. 3 variants

Ref The model number is consistent with the catalogue numberModel E-80S,E-80F, S-80S,S-80F, CM-5GL,CM-5,CM-3GL,CM-3,CM-GL

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 Number697287382E-80HV Basic UDI-DI Date21 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  • Withdrawn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

Device Name
Electrolyte Analyzer
Model / Reference
E-80S, E-80F, The model number is consistent with the catalogue number, S-80S, S-80F, CM-5GL, CM-5, CM-3GL, CM-3, CM-GL
Primary DI / UDI-DI
06972873820273, 06972873820280, 06972873820211, 06972873821744, 06972873821737, 06972873821720, 06972873820228
Basic UDI-DI
697287382E-80HV, 697287382S-80LX, 697287382CM55
Direct Marketing DI
06972873820273
06972873820280
06972873820211
06972873821744
06972873821737
06972873821720
06972873820228
EMDN Code
W0201040201 Ion selective electrolyte analysers
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

  • 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