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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 1 of 2

Device	Model / Reference	Registries	Class	Status
Hematology Reagent Kit	12600777	EUDAMED	Class A	Active
Direct Bilirubin/Total Protein/Alkaline Phosphatase/Glutamyl Transferase Reagent Kit	1G001	EUDAMED	IVD General	Active
GlucoMen® iCan	59061	EUDAMED	Class IIb	Active
iCan Review	N/A	EUDAMED	Class I	Active
Alanine Aminotransferase/Aspartate Aminotransferase/Total Bilirubin/Albumin Reagent Kit	1F001	EUDAMED	IVD General	Active
Portable Automatic Multi-Function Analyzer (iCARE-1300)	10500077	EUDAMED	Class A	Active
Safe AQ max Ⅲ	6D006DD	EUDAMED	IVD Annex II List B	Active
Blood Glucose Meter	1N002	EUDAMED	IVD devices for self-testing	Active
Sg-12	3G003DD	EUDAMED	IVD General	Active
Safe AQ Smart	2J002DD	EUDAMED	IVD Annex II List B	Active
Myocardial Enzyme Reagent Kit (CK, CK-MB, LDH, α -HBDH)	1T001	EUDAMED	IVD General	Active
Lipid Control Solution	12700036	EUDAMED	IVD General	Active
Serum amyloid A Reagent Kit	3H001	EUDAMED	IVD General	Active
Sinocare iCan	N/A	EUDAMED	Class IIb	Active
Blood Glucose Test Strip	1N003	EUDAMED	IVD devices for self-testing	Active
Gold AQ Blood Glucose Monitoring System	K170264	FDA 510(k)	Class II	Active
Blood Glucose and Uric Acid Meter	1V001	EUDAMED	IVD devices for self-testing	Active
Slx-120	3G001DD	EUDAMED	IVD General	Active
Blood Glucose Control Solution	1A003DD	EUDAMED	IVD Annex II List B	Active
Sinocare iCan	10600231	EUDAMED	Class IIb	Active
Procalcitonin	12600786	EUDAMED	IVD General	Active
Lipid Control Solution	12700037	EUDAMED	IVD General	Active
Procalcitonin Reagent Kit	2W001	EUDAMED	IVD General	Active
Urea/Creatinine/Uric Acid Reagent Kit	1N001	EUDAMED	IVD General	Active
Portable Automatic Multi-Function Analyzer (iCARE-1300)	10500075	EUDAMED	Class A	Active
Blood Glucose Test Strip	5Y002, 5Z002, 6A002, 6B002, 6B003, 6C001, 6C002, 6C003, 6C004, 6C005, 6C006, 6C007, 6D004, 6D005, 6D006	EUDAMED	IVD devices for self-testing	Active
Cardiac markers	12600789	EUDAMED	IVD General	Active
Sinocare	12600157	EUDAMED	IVD General	Active
Sinocare iCan	N/A	EUDAMED	Class IIb	Active
Blood Lipid Reagent Kit (TC/TG/HDL-C/LDL-C)	1J001	EUDAMED	IVD General	Active
Blood Glucose Meter	5D001	EUDAMED	IVD devices for self-testing	Active
2j002	2J002	EUDAMED	IVD Annex II List B	Active
Glycosylated Hemoglobin Test Kit	2K001	EUDAMED	IVD General	Active
Sinocare iCan	N/A	EUDAMED	Class IIb	Active
Sinocare iCan	N/A	EUDAMED	Class IIb	Active
Heart-type fatty acid-binding protein Reagent Kit	3A001	EUDAMED	IVD General	Active
Safe AQ UG	1V002DD	EUDAMED	IVD Annex II List B	Active
Uric Acid Test Strip	4B003	EUDAMED	IVD devices for self-testing	Active
Portable Automatic Multi-Function Analyzer (iCARE-1300)	10500074	EUDAMED	Class A	Active
Sinocare	12600137	EUDAMED	IVD General	Active
APTT/PT/TT/FIB Reagent Kit	1R001	EUDAMED	IVD General	Active
Sinocare iCan	N/A	EUDAMED	Class IIb	Active
25-hydroxy-vitamin D	12600787	EUDAMED	IVD General	Active
Urinary Microalbumin/Creatinine Reagent Kit (Fluorescence / Benedict-Behre method)	1X001	EUDAMED	IVD General	Active
Hematology Reagent Kit	12600777	EUDAMED	Class A	Active
C-Reactive Protein/Anti-streptolysin O/Rheumatoid Factor Reagent Kit	2U001	EUDAMED	IVD General	Active
Safe-Accu2	5D001DD	EUDAMED	IVD Annex II List B	Active
Safe AQ Smart	2J003DD	EUDAMED	IVD Annex II List B	Active
Ll-12	3G002DD	EUDAMED	IVD General	Active
Sinocare iCan	N/A	EUDAMED	Class IIb	Active

Changsha Sinocare Inc.

Information

Catalogue (98)

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