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Changsha Sinocare Inc.

China·CN-MF-000012244

Last updated September 17, 2026

Information

Country: China
Address: No.265 Guyuan Road, Hi-tech Zone, Changsha, China
Website: sinocare.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Siting Zhu
EUDAMED SRN: CN-MF-000012244
FDA FEI Number: 3016863723
DUNS Number: —

Catalogue (98)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
D-Dimer Reagent Kit	2N001	EUDAMED	IVD General	Active
Blood Glucose and Uric Acid Meter	4B002	EUDAMED	IVD devices for self-testing	Active
Blood Glucose Monitoring System	2J003; 2J004; 2K002; 2K003	EUDAMED	IVD Annex II List B	Active
Pepsinogen I/Pepsinogen II Reagent Kit	2X001	EUDAMED	IVD General	Active
Safe AQ max Ⅲ	6D001DD	EUDAMED	IVD Annex II List B	Active
Safe-Accu	1N002DD	EUDAMED	IVD Annex II List B	Active
Portable Automatic Multi-function Analyzer	3V001	EUDAMED	Class A	Active
Safe AQ max Ⅲ	6D003DD	EUDAMED	IVD Annex II List B	Active
Sinocare	12600161	EUDAMED	IVD General	Active
Safe-Accu	1N003DD	EUDAMED	IVD Annex II List B	Active
Electrolyte（CO2 ∕ Mg ∕ P ∕ Fe） Reagent Kit	2Z001	EUDAMED	IVD General	Active
Blood Glucose Control Solution	1A004DD	EUDAMED	IVD Annex II List B	Active
Total Bile Acid/Cholinesterase/α-Amylase Reagent Kit	1Y001	EUDAMED	IVD General	Active
β2-Microglobulin/Cystatin C Reagent Kit	1O001	EUDAMED	IVD General	Active
Sinocare iCan® view Glucose Data Reader	MDA 0204	EUDAMED	Class IIb	Active
Electrolyte（K∕ Na∕ Cl ∕Ca）Reagent Kit	2Y001	EUDAMED	IVD General	Active
Slx-121	3N001DD	EUDAMED	IVD General	Active
C-Reactive Protein Reagent Kit	1E001	EUDAMED	IVD General	Active
GlucoMen® iCan view Glucose Data Reader	MDA 0204	EUDAMED	Class IIb	Active
Glucose/Homocysteine/Uric Acid/Low Density Lipoprotein Cholesterol Reagent Kit	1Q001	EUDAMED	IVD General	Active
Prothrombin Time Reagent Kit	1S001	EUDAMED	IVD General	Active
Cardiac troponin I/Myoglobin/Creatine Kinase MB Reagent Kit	3B001	EUDAMED	IVD General	Active
Neutrophil gelatinase-associated lipocalin Reagent Kit	2M001	EUDAMED	IVD General	Active
Sinocare	12600550	EUDAMED	IVD General	Active
Sinocare	12600153	EUDAMED	IVD General	Active
Safe AQ proⅠ	5Y001DD	EUDAMED	IVD Annex II List B	Active
Safe AQ UG	1V003DD	EUDAMED	IVD Annex II List B	Active
Sinocare	12600551	EUDAMED	IVD General	Active
Blood Glucose and Uric Acid Meter	4B001	EUDAMED	IVD devices for self-testing	Active
Blood Glucose Test Strip	2B002	EUDAMED	IVD devices for self-testing	Active
Blood Glucose Meter	5Y001, 5Z001, 6A001, 6B001, 6C001, 6D001	EUDAMED	IVD devices for self-testing	Active
Homocysteine Reagent Kit	2P001	EUDAMED	IVD General	Active
β-humanchorionic gonadotrophin	12600785	EUDAMED	IVD General	Active
Sinocare	12600542	EUDAMED	IVD General	Active
Sinocare iCan	N/A	EUDAMED	Class IIb	Active
Sinocare iCan	N/A	EUDAMED	Class IIb	Active
C-Reactive Protein/Serum Amyloid A Reagent Kit	1Z001	EUDAMED	IVD General	Active
Glucose/Glycated Serum Albumin Reagent Kit	1U001	EUDAMED	IVD General	Active
Lipoprotein-associated Phospholipase A2 Reagent Kit	2L001	EUDAMED	IVD General	Active
Safe AQ UG	1V001DD	EUDAMED	IVD Annex II List B	Active
Ferritin	12600788	EUDAMED	IVD General	Active
Sinocare iCan	N/A	EUDAMED	Class IIb	Active
Glycated Hemoglobin Reagent Kit (Boric Acid Affinity Liquid Chromatography/Chromatography)	1P001	EUDAMED	IVD General	Active
Sinocare iCan	N/A	EUDAMED	Class IIb	Active
iCan CGM	N/A	EUDAMED	Class IIb	Active
Sinocare	12600545	EUDAMED	IVD General	Active
Safe AQ Voice	2K003DD	EUDAMED	IVD Annex II List B	Active
Immunoglobulin (IgA/IgG/IgM) Reagent Kit	2S001	EUDAMED	IVD General	Active

Changsha Sinocare Inc.

Information

Catalogue (98)

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