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Chitinase-3-like protein 1 (kit) （Colloidal Gold）

by Hangzhou Proprium Biotech Co.Ltd

Ref 20 tests/boxModel 1 test/bag, 20 tests/box

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 Number697576908PWC3LP1DA Basic UDI-DI 06975769080010UDI-DIDate28 Feb 2024RegisteredStatusActive

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  • Withdrawn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
Chitinase-3-like protein 1 (kit) （Colloidal Gold）
Model / Reference
1 test/bag, 20 tests/box
Primary DI / UDI-DI
06975769080010
Basic UDI-DI
697576908PWC3LP1DA
EMDN Code
W01010199 Enzymes - other
Device Class
Class A
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000035883
Authorised representative
Lotus NL B.V. NL-AR-000000121

Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No