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Chitinase 3-Like Protein 1 (CHI3L1) Rapid Quantitative Test

by Xenta Biomedical Science Co., Ltd. 2 variants

Ref XRDL078A105OS

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-06975278861414 Basic UDI-DI 06975278861414UDI-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  • Withdrawn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
Chitinase 3-Like Protein 1 (CHI3L1) Rapid Quantitative Test
Model / Reference
XRDL078A105OS
Primary DI / UDI-DI
06975278861414
Basic UDI-DI
B-06975278861414
EMDN Code
W0102019099 Specific proteins - 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

  • Animal Tissues
  • Microbial Substances
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No