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Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing)

by Xiamen Spacegen Co., Ltd. China EUDAMED

Ref Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]

EMDN W010699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972665700301 Basic UDI-DIDate21 Sep 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
Lotus NL B.V. Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. E-mail:[email protected]
Primary DI / UDI-DI
06972665700301
Basic UDI-DI
B-06972665700301
EMDN Code
W010699 Genetic tests - other
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000018018
Authorised representative
Lotus NL B.V. NL-AR-000000121

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 71e10b64-56cb-45c0-a6df-59a4d68ae78e 61 fields · synced 22 Oct 2026