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Snapshot 2026-10-28 · Link to EUDAMED

XIAMEN SPACEGEN CO.,LTD.

SRN CN-MF-000018018

manufacturer · Xiamen, CN · 37 devices

Room 401 of 4th floor of No.2041, 7th floor of No.2043, 4th floor of No.2045 Xizhou Road, Xike Town, Tong’an District, 361100

Devices

NameUDI-DIClassBadge
2019 Novel Coronavirus Antigen Rapid Test(Colloidal Gold)06972665703012Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

2019 Novel Coronavirus RNA Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)06972665701100Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

ALK/ROS1/RET Gene Fusion Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)06972665701124Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

B-raf Gene Mutation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)06972665701032Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

BRCA1/2 Gene Mutations Detection Kit (High Throughput Sequencing)06972665700103Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

BRCA1/2 Gene Mutations Detection Kit (High Throughput Sequencing)06972665700110Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Breast-Ovarian Cancer Combined Gene Detection Kit06972665700004Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Breast-Ovarian Cancer Combined Gene Detection Kit06972665700219Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Colorectal Cancer Related Gene Mutation Detection Kit(High Throughput Sequencing)06972665700332Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Colorectal Cancer Related Gene Mutation Detection Kit(High Throughput Sequencing)06972665700349Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)06972665701131Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Detection Kit for Monkeypox Virus DNA (PCR-Fluorescence Probing)06972665701148Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

EGFR Gene Mutations Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)06972665701063Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

EGFR Gene T790M Mutation Detection Kit (Digital PCR)06972665702015Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

EGFR Gene T790M Mutation Detection Kit (Digital PCR)06972665702022Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Homologous Recombination Deficiency (HRD) Panel Assay Kit06972665700363Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Human BCR-ABL Gene T315I Mutation Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)06972665701087Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Human Endometrial Cancer Molecular Classification Detection Kit (High Throughput Sequencing)06972665700257Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Human Endometrial Cancer Molecular Classification Detection Kit (High Throughput Sequencing)06972665700264Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Human Glioma 26 Gene Mutations Detection Kit06972665700226Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Human Glioma 26 Gene Mutations Detection Kit06972665700356Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Human Lung Tissue Mycobacteria Identification Detection Kit (Nucleic Acid Mass Spectrometry)06972665704019Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing)06972665700295Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Human Lynch Syndrome Gene Detection Kit (High Throughput Sequencing)06972665700301Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED

Human NTRK Genes Fusion Detection Kit (Multiplex Fluorescence Polymerase Chain Reaction)06972665701070Unknown class
No Certificate Found

Snapshot 2026-10-28 · Link to EUDAMED