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Homologous Recombination Deficiency (HRD) Panel Assay Kit

by Xiamen Spacegen Co., Ltd.

Ref SPG-HRD004Model 24 Tests/kit

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972665700363 Basic UDI-DI 06972665700363UDI-DIDate4 Mar 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  • Withdrawn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

Model / Reference
24 Tests/kit, SPG-HRD004
Primary DI / UDI-DI
06972665700363
Basic UDI-DI
B-06972665700363
EMDN Code
W0106030102 Cyp 450 - multiple tests on micro-arrays
Device Class
Class IVD General
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000018018
Authorised representative
JOYSUN GROUP S.L.U ES-AR-000043666

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Properties

  • Human Tissues
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing

Other properties (5)

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