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Fetal Chromosome Aneuploidy Detection Kit (Sequencing Method)

by GeneMind Biosciences Co., Ltd. China EUDAMED

Ref L000158-PModel 32 tests/kit (Pre-packaged) EMDN W0106010399

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974968584275 Basic UDI-DIDate7 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

TürkiyeTürkiyeTürkiyeTürkiyeTürkiyeTürkiye
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

EU market availability

Available in 1 country, as listed in EUDAMED:

  • Türkiye

Last checked 25 Oct 2026.

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
32 tests/kit (Pre-packaged), L000158-P
Primary DI / UDI-DI
06974968584275
Basic UDI-DI
B-06974968584275
EMDN Code
W0106010399 Chromosomal disorders tests - other
Device Class
Class IVD General
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000025785
Authorised representative
Umedwings Netherlands B.V. NL-AR-000000444

Other devices from GeneMind Biosciences Co., Ltd.

See all devices from GeneMind Biosciences Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 06974968584275|B-06974968584275 61 fields · synced 25 Oct 2026