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Sharay Anti-Myositis Antibody Profile IgG (CLIA)

by C-Luminary Biotechnology Co., Ltd. 31 variants

Ref 18182001Model Model 16: Sharay Anti-Ro-52 IgG, 100 Tests/kit

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE IVDD, withdrawn

Ended

Withdrawn

Date not published (CE IVDD)

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-06975070761691 Basic UDI-DI 06975070761691UDI-DIDate19 Feb 2024RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/IVDD Withdrawn

Specification

EUDAMED

Model / Reference
Model 16: Sharay Anti-Ro-52 IgG, 100 Tests/kit, 18182001
Primary DI / UDI-DI
06975070761691
Basic UDI-DI
B-06975070761691
EMDN Code
W0102109099 Auto-immune disease tests - other
Device Class
Class IVD General

Manufacturer details

EUDAMED SRN
CN-MF-000035089
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Other devices from C-Luminary Biotechnology Co., Ltd.

See all devices from C-Luminary Biotechnology Co., Ltd. →

Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (6)

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