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DiYaLab ZJG Biotech Co., Ltd

China·CN-MF-000048648

Last updated June 8, 2026

Information

Country: China
Address: Room 211, Building A, Room 203, 206 and 207, Building B No.36, Huada Road, , Zhangjiagang, Jiangsu, China
Website: fermatbiotech.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Jing Li
EUDAMED SRN: CN-MF-000048648
FDA FEI Number: —
DUNS Number: —

Catalogue (133)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
FT3 Assay Kit (Fluorescence Immunoassay)	DL248901	EUDAMED	IVD General	Active
Testosterone Assay Kit (Fluorescence Immunoassay)	DL247901	EUDAMED	IVD General	Active
LH Assay Kit (Fluorescence Immunoassay)	DL247601	EUDAMED	IVD General	Active
FT4 Assay Kit (Fluorescence Immunoassay)	DL249001	EUDAMED	IVD General	Active
Prolactin Assay Kit (Fluorescence Immunoassay)	DL246901	EUDAMED	IVD General	Active
β- HCG Assay Kit (Fluorescence Immunoassay)	DL248001	EUDAMED	IVD General	Active
T3 Assay Kit (Fluorescence Immunoassay)	DL248101	EUDAMED	IVD General	Active
FSH Assay Kit (Fluorescence Immunoassay)	DL247701	EUDAMED	IVD General	Active
CEA Assay Kit (Fluorescence Immunoassay)	DL248801	EUDAMED	IVD General	Active
Anti-gliadin Antibody IgA /IgG Assay Kit (Fluorescence Immunoassay)	DL2514201	EUDAMED	IVD General	Active
AMH Assay Kit (Fluorescence Immunoassay)	AMH Assay Kit (Fluorescence Immunoassay)	EUDAMED	IVD General	Active
TSH Assay Kit (Fluorescence Immunoassay)	DL246801	EUDAMED	IVD General	Active
PSA Assay Kit (Fluorescence Immunoassay)	DL248601	EUDAMED	IVD General	Active
Anti-Sm Antibody IgG CLIA Assay Kit	CL30372E	EUDAMED	IVD General	Active
AFP Assay Kit (Fluorescence Immunoassay)	DL248701	EUDAMED	IVD General	Active
Anti-dsDNA CLIA Assay Kit	CL30082E	EUDAMED	IVD General	Active
Anti-Scl-70 Antibody CLIA Assay Kit	CL30402E	EUDAMED	IVD General	Active
Anti-Cardiolipin IgA CLIA Assay Kit	CL30012E	EUDAMED	IVD General	Active
ENA Assay Kit (Fluorescence Immunoassay)	DL2515301	EUDAMED	IVD General	Active
T4 Assay Kit (Fluorescence Immunoassay)	DL248201	EUDAMED	IVD General	Active
Anti-Sm/nRNP Antibody CLIA Assay Kit	CL30392E	EUDAMED	IVD General	Active
T3 CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-PR3 CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
C- reactive Protein Assay Kit (Fluorescence Immunoassay)	20 tests/ kit.	EUDAMED	IVD General	Active
Anti-dsDNA Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
Anti-GBM Assay Kit (Fluorescence Immunoassay)	DL213205	EUDAMED	IVD General	Active
Anti-Sm Assay Kit (Fluorescence Immunoassay)	DL234006	EUDAMED	IVD General	Active
PTH CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Thyroglobulin CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
TGAb CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Helicobacter Pylori Antigen Test（Fluorescence Immunoassay）	DL247102	EUDAMED	IVD General	Active
Ferritin Assay Kit（Fluorescence Immunoassay）	DL202205	EUDAMED	IVD General	Active
IA-2A Assay Kit (Fluorescence Immunoassay)	DL246602	EUDAMED	IVD General	Active
Free T3 CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-Cardiolipin IgG CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-Scl-70 Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
Anti-tTg IgA CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-Jo-1 Antibody CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Calprotectin Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
Anti-Scl-70 Assay Kit (Fluorescence Immunoassay)	DL234406	EUDAMED	IVD General	Active
Anti-Sm Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
Free IgE Assay Kit (Fluorescence Immunoassay)	DL245506	EUDAMED	IVD General	Active
Anti-SSA CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-tTg IgG CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-SSB CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-β2-GPI Domain 1 IgG Assay Kit (Fluorescence Immunoassay)	20T	EUDAMED	IVD General	Active
N-terminal pro-brain nitric peptide Assay Kit (Fluorescence Immunoassay)	DL190805	EUDAMED	IVD General	Active
U1-RNP Assay Kit (Fluorescence Immunoassay)	DL234106	EUDAMED	IVD General	Active
Anti-Cardiolipin IgA CLIA Assay Kit	100 tests/kit	EUDAMED	IVD General	Active
Anti-cyclic citrullinic peptide antibody Assay Kit(Fluorescence Immunoassay)	DL191405	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

SUNGO Europe B.V. NL

Importers

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Notified Bodies

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Authorities

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