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Thyroid carcinoma RET Gene Fusions Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)

by Xiamen Spacegen Co., Ltd. China EUDAMED

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

EMDN W010699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972665701056 Basic UDI-DIDate7 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. Address:Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands. Email:[email protected]
Primary DI / UDI-DI
06972665701056
Basic UDI-DI
B-06972665701056
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

Other devices from Xiamen Spacegen Co., Ltd.

See all devices from Xiamen Spacegen Co., Ltd. →

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 ca317e58-0d90-45d4-96b0-e6dbafda1f6b 61 fields · synced 22 Oct 2026