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Light-initiated Chemiluminescent Immunoanalyzer

by Xenta Biomedical Science Co., Ltd.

Ref XIRD001A1

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975278861780 Basic UDI-DI 06975278861780UDI-DIDate8 Sep 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  • Withdrawn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

Device Name
Light-initiated Chemiluminescent Immunoanalyzer
Model / Reference
XIRD001A1
Primary DI / UDI-DI
06975278861780
Basic UDI-DI
B-06975278861780
EMDN Code
W02010299 Immunochemistry instruments - other
Device Class
Class IVD General
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000057746
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Xenta Biomedical Science Co., Ltd.

See all devices from Xenta Biomedical Science Co., Ltd. →

Properties

  • Near-Patient Testing
  • Surgical Instrument

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • New Device: No