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BRCA NGS Test Kit

by Genes 2Me Private Limited 11 variants

Ref G710001‑8Model G710001

Active European Union

CE IVDD

Valid until

No date given

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/IVDD NumberB-08906178202142 Basic UDI-DI 08906178202142UDI-DIDate22 Sep 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  • Withdrawn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
G710001, G710001‑8
Primary DI / UDI-DI
08906178202142
Basic UDI-DI
B-08906178202142
EMDN code
W01060203 Brca 1+2
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
IN-MF-000035953
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • Reagent
  • IVD kit
  • Professional testing

Other properties (9)

  • Supplied sterile: No
  • Sterilise before use: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains substances of microbial origin: No
  • Self-testing: No
  • Near-patient testing: No
  • Companion diagnostics: No
  • IVD instrument: No