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Suzhou GenePlus Biomedical Engineering Co., Ltd.

China·CN-MF-000035774

Last updated June 8, 2026

Information

Country: China
Address: Unit 101 and 201, Building B11, BioBay, No. 218 Xinghu Street, Suzhou Industrial Park, Suzhou City, Jiangsu Province, China, Suzhou, China
Website: geneplus.org.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86 0512-62625961
PRRC Contact: Yuxing Chu
EUDAMED SRN: CN-MF-000035774
FDA FEI Number: —
DUNS Number: —

Catalogue (15)

Device	Model / Reference	Registries	Class	Status
Oncology 188-Gene Variant Assay (HT)	102122303	EUDAMED	IVD General	Active
Oncology 188-Gene Variant Assay	102122401	EUDAMED	IVD General	Active
Focused Ultrasonicator	EB5002	EUDAMED	Class A	Active
Comprehensive Pathogen NA Test Kit	101122103	EUDAMED	IVD General	Active
Oncology Fusion-Gene Variant Assay (M)	117121302	EUDAMED	IVD General	Active
Comprehensive Genomic Profiling Based MRD Detection Assay (M)	106021302	EUDAMED	IVD General	Active
Gene+Box Data Analysis and Management System	ED5001	EUDAMED	Class A	Active
Oncology Fusion-Gene Variant Assay	117122301	EUDAMED	IVD General	Active
Circulating Tumour DNA 1021-Gene Variant Assay	KB5003048	EUDAMED	IVD General	Active
Comprehensive Multi-Gene Variant Assay	103122301	EUDAMED	IVD General	Active
Oncology 59-Gene Variant Assay	KB5005048	EUDAMED	IVD General	Active
Automated Workstation	EB5001	EUDAMED	Class A	Active
Oncology HRD Assay (M)	115021301	EUDAMED	IVD General	Active
Oncology Multi-Gene Variant Assay	KB5002048	EUDAMED	IVD General	Active
Oncology 188-Gene Variant Assay (M)	102121303	EUDAMED	IVD General	Active

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