Skip to content

Cardiac Injury Marker Test Device (Serum/plasma/whole blood)

by Neo-nostics (Suzhou) Bioengineering Co., Ltd.

Ref CAR0239

Active European Union

CE IVDD

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-86979834610337 Basic UDI-DI 86979834610337UDI-DIDate25 May 2026RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
CAR0239
Primary DI / UDI-DI
86979834610337
Basic UDI-DI
B-86979834610337
EMDN Code
W0102160799 Cardiac markers - rt & poc - other
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000013087
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Neo-nostics (Suzhou) Bioengineering Co., Ltd.

See all devices from Neo-nostics (Suzhou) Bioengineering Co., Ltd. →

Properties

  • Professional Testing

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
  • Surgical Instrument: No