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Wuhan Life Origin Biotech Joint Stock Co., Ltd.

China·CN-MF-000027340

Last updated June 8, 2026

Information

Country: China
Address: Floor 1st, 2nd and 3rd, Wuhan Hi-tech Medical Device Park B11,No.818 Gaoxin Avenue, Donghu Hi- Tech Development Zone, Wuhan, Hubei, China
Website: szybio.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Zhen Chen
EUDAMED SRN: CN-MF-000027340
FDA FEI Number: —
DUNS Number: —

Catalogue (172)

Page 1 of 4

Device	Model / Reference	Registries	Class	Status
Carcinoembryonic Antigen (CEA) Assay Kit (Chemiluminescent Immunoassay)	100 Tests/Kit	EUDAMED	IVD General	Active
PepsinogenⅡ (PGⅡ) Assay Kit (Chemiluminescent Immunoassay)	100 Tests/Kit	EUDAMED	IVD General	Active
Total Prostate Specific Antigen (tPSA) Assay Kit (Chemiluminescent Immunoassay)	25 Tests/Kit	EUDAMED	IVD General	Active
Heart-type Fatty Acid Binding Protein (H-FABP) Assay Kit (Chemiluminescent Immunoassay)	100 Tests/Kit	EUDAMED	IVD General	Active
Myoglobin/CK-MB/Troponin I Assay Kit (Fluorescence Immunochromatography)	10 tests/kit	EUDAMED	IVD General	Active
Thyroglobulin (TG) Assay Kit (Chemiluminescent Immunoassay)	100 Tests/Kit	EUDAMED	IVD General	Active
Free Triiodothyronine (FT3) Assay Kit (Chemiluminescent Immunoassay)	100 Tests/Kit	EUDAMED	IVD General	Active
Follicle-Stimulating Hormone (FSH) Assay Kit (Chemiluminescent Immunoassay)	50 Tests/Kit	EUDAMED	IVD General	Active
D-dimer Determination Kit (Fluorescence Immunochromatography)	25tests/kit	EUDAMED	IVD General	Active
Laminin (LN) Assay Kit (Chemiluminescent Immunoassay)	100 Tests/Kit	EUDAMED	IVD General	Active
Thyrold Stimulating Hormone Assay Kit (Immunochromatographic Assay)	50 tests/kit	EUDAMED	IVD General	Active
Estradiol (E2) Assay Kit (Chemiluminescent Immunoassay)	50 Tests/Kit	EUDAMED	IVD General	Active
Estradiol (E2) Assay Kit (Chemiluminescent Immunoassay)	25 Tests/Kit	EUDAMED	IVD General	Active
PepsinogenⅡ (PGⅡ) Assay Kit (Chemiluminescent Immunoassay)	50 Tests/Kit	EUDAMED	IVD General	Active
Follicle-Stimulating Hormone (FSH) Assay Kit (Chemiluminescent Immunoassay)	100 Tests/Kit	EUDAMED	IVD General	Active
Vitamin B12 (VB12) Assay Kit (Chemiluminescent Immunoassay)	100 Tests/Kit	EUDAMED	IVD General	Active
Thyroglobulin (TG) Assay Kit (Chemiluminescent Immunoassay)	50 Tests/Kit	EUDAMED	IVD General	Active
Free Prostate Specific Antigen (fPSA) Assay Kit (Chemiluminescent Immunoassay)	25 Tests/Kit	EUDAMED	IVD General	Active
Free Prostate Specific Antigen (fPSA) Assay Kit (Chemiluminescent Immunoassay)	100 Tests/Kit	EUDAMED	IVD General	Active
Interleukin 6 Determination Kit （Fluorescence Immunochromatography）	25 Tests/Kit	EUDAMED	IVD General	Active
Carbohydrate Antigen 19-9 (CA19-9) Assay Kit (Chemiluminescent Immunoassay)	100 Tests/Kit	EUDAMED	IVD General	Active
Myoglobin Assay Kit (Immunochromatographic Assay)	50 tests/kit	EUDAMED	IVD General	Active
Luteinizing Hormone Assay Kit (Immunochromatographic Assay)	10 tests/kit	EUDAMED	IVD General	Active
Small Dry Fluorescence Immunoassay Analyzer	FIC-H0	EUDAMED	Class A	Active
Serum Amyloid A Protein(SAA) Assay Kit(Chemiluminescent Immunoassay)	200 Tests/Kit	EUDAMED	IVD General	Active
Folate (FA) Assay Kit (Chemiluminescent Immunoassay)	50 Tests/Kit	EUDAMED	IVD General	Active
Gastrin-17(G-17) Assay Kit (Chemiluminescent Immunoassay)	Gastrin-17(G-17) Assay Kit (Chemiluminescent Immunoassay)	EUDAMED	IVD General	Active
Free Prostate Specific Antigen (fPSA) Assay Kit (Chemiluminescent Immunoassay)	50 Tests/Kit	EUDAMED	IVD General	Active
Ferritin Assay Kit (Immunochromatographic Assay)	50 tests/kit	EUDAMED	IVD General	Active
Dry Immunofluorescence Analyzer	SZY-1100	EUDAMED	Class A	Active
Myoglobin(MYO) Assay Kit(Chemiluminescent Immunoassay)	100 Tests/Kit	EUDAMED	IVD General	Active
Carbohydrate Antigen 19-9 (CA19-9) Assay Kit (Chemiluminescent Immunoassay)	25 Tests/Kit	EUDAMED	IVD General	Active
Carcinoembryonic AntigenAssay Kit (Immunochromatographic Assay)	25 tests/kit	EUDAMED	IVD General	Active
Ferritin Assay Kit (Immunochromatographic Assay)	100 tests/kit	EUDAMED	IVD General	Active
Alpha Fetoprotein Assay Kit (Immunochromatographic Assay)	50 tests/kit	EUDAMED	IVD General	Active
Beta Human Chorionic Gonadotropin Assay Kit (Immunochromatographic Assay)	25 tests/kit	EUDAMED	IVD General	Active
Free Testosterone (FT) Assay Kit (Chemiluminescent Immunoassay)	50 Tests/Kit	EUDAMED	IVD General	Active
Adrenocor Ticotropic Hormore (ACTH) Assay Kit (Chemiluminescent Immunoassay)	50 Tests/Kit	EUDAMED	IVD General	Active
Anti-Mullerian Hormone (AMH) Assay Kit (Chemiluminescent Immunoassay)	50 Tests/Kit	EUDAMED	IVD General	Active
Follicle Stimulating Hormone Assay Kit (Immunochromatographic Assay)	10 tests/kit	EUDAMED	IVD General	Active
Progesterone (PROG) Assay Kit (Chemiluminescent Immunoassay)	50 Tests/Kit	EUDAMED	IVD General	Active
Human Epididymis Protein 4 (HE4) Assay Kit (Chemiluminescent Immunoassay)	25 Tests/Kit	EUDAMED	IVD General	Active
Glycated Hemoglobin Assay Kit （Fluorescence Immunochromatography）	50 tests/kit	EUDAMED	IVD General	Active
Procalcitonin Assay Kit (Fluorescence Immunochromatography)	25tests/kit	EUDAMED	IVD General	Active
Creatine Kinase Isoenzyme Assay Kit (Immunochromatographic Assay)	25 tests/kit	EUDAMED	IVD General	Active
nterleukin 6(IL-6) Assay Kit(Chemiluminescent Immunoassay)	200 Tests/Kit	EUDAMED	IVD General	Active
PepsinogenⅡ (PGⅡ) Assay Kit (Chemiluminescent Immunoassay)	25 Tests/Kit	EUDAMED	IVD General	Active
Ferritin Assay Kit (Immunochromatographic Assay)	25 tests/kit	EUDAMED	IVD General	Active
Free Thyroxine (FT4) Assay Kit (Chemiluminescent Immunoassay)	50 Tests/Kit	EUDAMED	IVD General	Active
Chemiluminescence Immunoassay Analyzer	SZY-CL1000	EUDAMED	Class A	Active

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SUNGO Europe B.V. NL

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Authorities

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