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Coei Biotech Co.Ltd.

China·CN-MF-000049509

Last updated September 17, 2026

Information

Country: China
Address: 5th Floor, F8, Workshop 8, Science & Technology Incubation Park, Changchun, China
Website: conminbiotech.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: ZHENKUN LUO
EUDAMED SRN: CN-MF-000049509
FDA FEI Number: —
DUNS Number: —

Catalogue (70)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
Triglycerides Reagent Kit( Enzyme Method)	5232	EUDAMED	IVD General	Active
Urine control	6532	EUDAMED	IVD General	Active
Colloidal Gold & Fluorescence Analyzer	9812	EUDAMED	Class A	Active
Tumor Marker Control	6932	EUDAMED	IVD General	Active
HbA1c Control	6032	EUDAMED	IVD General	Active
D-dimer Control	6432	EUDAMED	IVD General	Active
iFOB Control	6732	EUDAMED	IVD General	Active
Cholesterol Kit( Enzyme Method)	5132	EUDAMED	IVD General	Active
Creatinine Kit(Enayme Method)	5032	EUDAMED	IVD General	Active
Calcium Kit(Cresolphthalein Complexone Method)	5832	EUDAMED	IVD General	Active
Uric Acid Kit( Uricase Method)	4932	EUDAMED	IVD General	Active
Anemia Control	6832	EUDAMED	IVD General	Active
Glucose Kit(Hexokinase Method)	5632	EUDAMED	IVD General	Active
Urea Kit( Enzyme Method)	4832	EUDAMED	IVD General	Active
High Density Lipoprotein Cholesterol Kit(Direct Method)	5332	EUDAMED	IVD General	Active
Inflammation Markers Control	6332	EUDAMED	IVD General	Active
PCT (Procalcitonin) Rapid Quantitative Test	1842	EUDAMED	IVD General	Active
TSH (Thyroid-stimulating hormone) Rapid Quantitative Test	1242	EUDAMED	IVD General	Active
Low Density Lipoprotein Cholesterol Kit(Direct Method)	5432	EUDAMED	IVD General	Active
Dry Fluorescence Immunoassay Analyzer	9922	EUDAMED	Class A	Active
Dry Fluorescence Immunoassay Analyzer	9912	EUDAMED	Class A	Active
Cardiac Markers Control	6232	EUDAMED	IVD General	Active
Glucose Kit(Glucose Oxidase Method)	5732	EUDAMED	IVD General	Active
HbA1c Rapid Quantitative Test	1142	EUDAMED	IVD General	Active
H.Pylori Ag Control	6632	EUDAMED	IVD General	Active
T4 (Thyroxine) Rapid Quantitative Test	1342	EUDAMED	IVD General	Active
hsCRP Rapid Quantitative Test	0442	EUDAMED	IVD General	Active
E2 Rapid Quantitative Test	3642	EUDAMED	IVD General	Active
β-hCG Rapid Quantitative Test	1442	EUDAMED	IVD General	Active
PRL Rapid Quantitative Test	2742	EUDAMED	IVD General	Active
FSH Rapid Quantitative Test	3242	EUDAMED	IVD General	Active
cTnI Rapid Quantitative Test	0842	EUDAMED	IVD General	Active
Total Protein Kit (Biuret Method)	4732	EUDAMED	IVD General	Active
Albumin Kit (Bromcresol Green Method)	4332	EUDAMED	IVD General	Active
T4 (Thyroxine) Rapid Quantitative Test	1342	EUDAMED	IVD General	Active
LH Rapid Quantitative Test	2642	EUDAMED	IVD General	Active
CK-MB Rapid Quantitative Test	0642	EUDAMED	IVD General	Active
HbA1c Rapid Quantitative Test	1142	EUDAMED	IVD General	Active
Cortisol Rapid Quantitative Test	3742	EUDAMED	IVD General	Active
hs-CRP+CRP Rapid Quantitative Test	1742	EUDAMED	IVD General	Active
AMH Rapid Quantitative Test	2942	EUDAMED	IVD General	Active
Total IgE Rapid Quantitative Test	3842	EUDAMED	IVD General	Active
SAA (Serum Amyloid A Protein) Rapid Quantitative Test	1942	EUDAMED	IVD General	Active
NT-proBNP Rapid Quantitative Test	0742	EUDAMED	IVD General	Active
IL-6 Rapid Quantitative Test	3042	EUDAMED	IVD General	Active
Total Bilirubin Kit(Diazo Salt Method)	4532	EUDAMED	IVD General	Active
MAU Rapid Quantitative Test	2242	EUDAMED	IVD General	Active
Vitamin B12 Rapid Quantitative Test	3142	EUDAMED	IVD General	Active
CRP (C-reactive protein) Rapid Quantitative Test	1642	EUDAMED	IVD General	Active
fT3 Rapid Quantitative Test	2542	EUDAMED	IVD General	Active

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Notified Bodies

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Authorities

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