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 Yellow Fever NS1 Antigen Rapid Test	06977903348628	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Zika NS1 Antigen Rapid Test	06977903349113	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Zika NS1 Antigen Rapid Test	06977903349120	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Zika Virus IgG/IgM Rapid Test	06977903349014	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign Zika Virus IgG/IgM Rapid Test	06977903349021	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign β-HCG FIA	06977903340134	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
GeneSign β-HCG FIA	06977903340141	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
HAV IgM/IgG Rapid Test	06977903343210	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
HAV IgM/IgG Rapid Test	06977903343227	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
HbA1C FIA	06977903345214	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
HbA1C FIA	06977903345221	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
HCG Pregnancy Rapid Test Card/ HCG Pregnancy Rapid Test Strip/ HCG Pregnancy Rapid Test Midstream	06977903340110	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
HCG Pregnancy Rapid Test Card/ HCG Pregnancy Rapid Test Strip/ HCG Pregnancy Rapid Test Midstream	06977903340127	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
HPV 16/18 E7 Antigen Rapid Test	06977903344316	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
HPV 16/18 E7 Antigen Rapid Test	06977903344323	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
HPV Antigen Rapid Test	06977903342718	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
HPV Antigen Rapid Test	06977903342725	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
HPV L1/E7 Antigen Rapid Test	06977903344415	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
HPV L1/E7 Antigen Rapid Test	06977903344422	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
H. Pylori Antigen Rapid Test	06977903341018	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
H. Pylori Antigen Rapid Test	06977903341025	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
HSV-II IgM/IgG Rapid Test	06977903344118	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
HSV-II IgM/IgG Rapid Test	06977903344125	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
IgE FIA	06977903345818	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
IgE FIA	06977903345825	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED