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Human anti-salivary gland protein I antibody CLlA Kit (IgA)

by Guangzhou Kangrun Biotech Co., Ltd. 3 variants

Ref CK-2486-050A

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-CK-2486-050A8Y Basic UDI-DI D-CK-2486-050A8YUDI-DIDate10 Dec 2025RegisteredStatusActive

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  • Withdrawn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
Human anti-salivary gland protein I antibody CLlA Kit (IgA)
Model / Reference
CK-2486-050A
Primary DI / UDI-DI
D-CK-2486-050A8Y
Basic UDI-DI
B-CK-2486-050A8Y
EMDN Code
W0102100199 Autoimmune connective tissue diseases testing - other
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000032267
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from Guangzhou Kangrun Biotech Co., Ltd.

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No