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Diagnostic Kit For the Detection of IFI44L Gene Methylation of Systemic Lupus erythematosus (SLE) (MS-HRM Method)

by Shenzhen Sciarray Biotech Co., Ltd.

Ref 20 tests/pacModel 20 tests/pac; 40 tests/pac

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-06975491762000 Basic UDI-DI 06975491762000UDI-DIDate3 Aug 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  • Withdrawn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
Diagnostic Kit For the Detection of IFI44L Gene Methylation of Systemic Lupus erythematosus (SLE) (MS-HRM Method)
Model / Reference
20 tests/pac, 40 tests/pac
Primary DI / UDI-DI
06975491762000
Basic UDI-DI
B-06975491762000
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000038307
Authorised representative
SUNGO Europe B.V. NL-AR-000000247

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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