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NOVEOS X Automatic Chemiluminescence Immunoassay Analyzer

by Shanghai Medconn Medical Technology Co., Ltd.

Model NOVEOS X

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number695441761106R72T Basic UDI-DI 06954417600138UDI-DIDate21 Nov 2023RegisteredStatusActive

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  • Withdrawn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
NOVEOS X Automatic Chemiluminescence Immunoassay Analyzer
Model / Reference
NOVEOS X
Primary DI / UDI-DI
06954417600138
Basic UDI-DI
695441761106R72T
Direct Marketing DI
06954417600138
EMDN Code
W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
Device Class
Class A
EU market of registration
Northern Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000038658
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Shanghai Medconn Medical Technology Co., Ltd.

Properties

  • Human Tissues
  • Professional Testing
  • Surgical Instrument
  • New Device

Other properties (7)

  • Sterile: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No