GeneSign Biotech (Xiamen)Co., Ltd.

SRN CN-MF-000044463

manufacturer · Xiamen, CN · 228 devices

Unit 03, 8th Floor, Building B14 Xiamen Biomedical, Industrial Park, 2076 Wengjiao West Road, Haicang District, 361000

Devices

Name	UDI-DI	Class	Badge
GeneSign PRL FIA	06977903340233	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign PRL FIA	06977903340240	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Progesterone FIA	06977903340530	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Progesterone FIA	06977903340547	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Rapid Norovirus I+II/Rota/Adeno/Astv Ag Test	06977903348819	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Rapid Norovirus I+II/Rota/Adeno/Astv Ag Test	06977903348826	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Respiratory Combo Antigen Rapid Test (Swab Specimen) (COVID-19/Flu A/ Flu B/RSV/ADV/MP/hMPV/HPIV/RhV/Strep A/S. Pneumoniae/L. Pneumophila)	06977903347911	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Respiratory Combo Antigen Rapid Test (Swab Specimen) (COVID-19/Flu A/ Flu B/RSV/ADV/MP/hMPV/HPIV/RhV/Strep A/S. Pneumoniae/L. Pneumophila)	06977903347928	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Respiratory Combo Antigen Rapid Test (Swab Specimen) (COVID-19/Flu A/ Flu B/RSV/ADV/MP/hMPV/Strep A/RhV)	06977903347812	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Respiratory Combo Antigen Rapid Test (Swab Specimen) (COVID-19/Flu A/ Flu B/RSV/ADV/MP/hMPV/Strep A/RhV)	06977903347829	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign SFTSV Antigen Rapid Test	06977903348710	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign SFTSV Antigen Rapid Test	06977903348727	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign SP-10 Male Fertility Rapid Test	06977903349212	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign SP-10 Male Fertility Rapid Test	06977903349229	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign TB IgG/IgM Rapid Test	06977903349311	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign TB IgG/IgM Rapid Test	06977903349328	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign TESTO FIA	06977903340738	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign TESTO FIA	06977903340745	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign TT3 FIA	06977903349915	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign TT3 FIA	06977903349922	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign TT4 FIA	06977903349816	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign TT4 FIA	06977903349823	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign West Nile Virus Antigen Rapid Test	06977903348918	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign West Nile Virus Antigen Rapid Test	06977903348925	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Yellow Fever NS1 Antigen Rapid Test	06977903348611	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED