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
Rotavirus Antigen Rapid Test	06977903342114	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Rotavirus Antigen Rapid Test	06977903342121	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
RSV Antigen Rapid Test	06977903344514	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
RSV Antigen Rapid Test	06977903344521	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Salmonella Typhi/ Paratyphi Antigen Rapid Test	06977903342510	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Salmonella Typhi/ Paratyphi Antigen Rapid Test	06977903342527	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Strep A Antigen Rapid Test	06977903344811	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Strep A Antigen Rapid Test	06977903344828	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Syphilis Rapid Test	06977903341216	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Syphilis Rapid Test	06977903341223	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Troponin I/Myoglobin/CK-MB Rapid Test	06977903342213	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Troponin I/Myoglobin/CK-MB Rapid Test	06977903342220	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Troponin I Rapid Test	06977903341414	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Troponin I Rapid Test	06977903341421	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
TSH FIA	06977903345610	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
TSH FIA	06977903345627	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Typhoid IgG/IgM Rapid Test	06977903344217	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Typhoid IgG/IgM Rapid Test	06977903344224	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Vibrio Cholerae O139 Antigen Rapid Test	06977903343913	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Vibrio Cholerae O139 Antigen Rapid Test	06977903343920	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Vibrio Cholerae O1 Antigen Rapid Test	06977903343814	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Vibrio Cholerae O1 Antigen Rapid Test	06977903343821	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Vibrio Cholerae O1/O139 Antigen Rapid Test	06977903344019	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Vibrio Cholerae O1/O139 Antigen Rapid Test	06977903344026	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Vitamin B12 FIA	06977903346716	Unknown class	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED