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HANGZHOU AICHEK MEDICAL TECHNOLOGY CO., LTD.

China·CN-MF-000028093

Last updated September 17, 2026

Information

Country: China
Address: 3rd Floor, Building 9, Hexiang Technology Center, Xiasha Street, Qiantang District,, Hangzhou, Zhejiang, China
Website: aichek.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Lisa Liu
EUDAMED SRN: CN-MF-000028093
FDA FEI Number: 3025349997
DUNS Number: —

Catalogue (282)

Page 1 of 6

Device	Model / Reference	Registries	Class	Status
Fluorescence Immunoassay Analyzer	AFE-101	EUDAMED	Class A	Active
Copper Reagent Kit	Cu6011Y, Cu6012Y, Cu6013Y, Cu6014Y, Cu6015Y, Cu6011N, Cu6012N, Cu6013N, Cu6014N, Cu6015N	EUDAMED	IVD General	Active
Retinol-Binding Protein Reagent Kit	RBP6021Y, RBP6022Y, RBP6023Y, RBP6024Y, RBP6025Y, RBP6021N, RBP6022N, RBP6023N, RBP6024N, RBP6025N	EUDAMED	IVD General	Active
Total Protein in Urine Reagent Kit	TPU6011Y, TPU6012Y, TPU6013Y, TPU6014Y, TPU6015Y, TPU6011N, TPU6012N, TPU6013N, TPU6014N, TPU6015N	EUDAMED	IVD General	Active
Myoglobin Reagent Kit	MB6011Y, MB6012Y, MB6013Y, MB6014Y, MB6015Y, MB6011N, MB6012N, MB6013N, MB6014N, MB6015N	EUDAMED	IVD General	Active
AFP Alpha-Fetoprotein (CLIA)	AFP706-AE10Y, AFP706-AE10N, AFP706-AE20Y, AFP706-AE20N	EUDAMED	IVD General	Active
FT3 Free Triiodothyronine (CLIA)	FT3706-AE10Y, FT3706-AE10N, FT3706-AE20Y, FT3706-AE20N	EUDAMED	IVD General	Active
Apolipoprotein C2 Reagent Kit	APOC26011Y, APOC26012Y, APOC26013Y, APOC26014Y, APOC26015Y, APOC26011N, APOC26012N, APOC26013N, APOC26014N, APOC26015N	EUDAMED	IVD General	Active
Cardiac Troponin I Reagent Kit	cTnI6011Y, cTnI6012Y, cTnI6013Y, cTnI6014Y, cTnI6015Y, cTnI6011N, cTnI6012N, cTnI6013N, cTnI6014N, cTnI6015N	EUDAMED	IVD General	Active
Apolipoprotein A2 Reagent Kit	APOA26011Y, APOA26012Y, APOA26013Y, APOA26014Y, APOA26015Y, APOA26011N, APOA26012N, APOA26013N, APOA26014N, APOA26015N	EUDAMED	IVD General	Active
Automatic Chemiluminescence lmmunoanalyzer	AI 2600, AI 2610, AI 2620, AI 2660, AI 2680	EUDAMED	Class A	Active
Sodium Reagent Kit	Na6011Y, Na6012Y, Na6013Y, Na6014Y, Na6015Y, Na6011N, Na6012N, Na6013N, Na6014N, Na6015N	EUDAMED	IVD General	Active
Lipase Reagent Kit	LPS6011Y, LPS6012Y, LPS6013Y, LPS6014Y, LPS6015Y, LPS6011N, LPS6012N, LPS6013N, LPS6014N, LPS6015N	EUDAMED	IVD General	Active
α₂-Macroglobulin Reagent Kit	α2-MG6011Y, α2-MG6012Y, α2-MG6013Y, α2-MG6014Y, α2-MG6015Y, α2-MG6011N, α2-MG6012N, α2-MG6013N, α2-MG6014N, α2-MG6015N	EUDAMED	IVD General	Active
Homocysteine Reagent Kit	HCY6011Y, HCY6012Y, HCY6013Y, HCY6014Y, HCY6015Y, HCY6011N, HCY6012N, HCY6013N, HCY6014N, HCY6015N	EUDAMED	IVD General	Active
Glycohemoglobin A1c Reagent Kit	HbA1c-S6011Y,HbA1c-S6012Y,HbA1c-S6013Y,HbA1c-S6014Y,HbA1c-S6015Y,HbA1c-S6011N,HbA1c-S6012N,HbA1c-S6013N,HbA1c-S6014N	EUDAMED	IVD General	Active
α₁-Microglobulin Reagent Kit	α1-MG6011Y, α1-MG6012Y, α1-MG6013Y, α1-MG6014Y, α1-MG6015Y, α1-MG6011N, α1-MG6012N, α1-MG6013N, α1-MG6014N, α1-MG6015N	EUDAMED	IVD General	Active
Potassium Reagent Kit	K6011Y, K6012Y, K6013Y, K6014Y, K6015Y, K6011N, K6012N, K6013N, K6014N, K6015N	EUDAMED	IVD General	Active
Creatine Kinase Reagent Kit	CK6011Y, CK6012Y, CK6013Y, CK6014Y, CK6015Y, CK6011N, CK6012N, CK6013N, CK6014N, CK6015N	EUDAMED	IVD General	Active
High Sensitivity C-Reactive Protein Reagent Kit	HS-CRP6011Y,HS-CRP6012Y,HS-CRP6013Y,HS-CRP6014Y,HS-CRP6015Y,HS-CRP6011N,HS-CRP6012N,HS-CRP6013N,HS-CRP6014N,HS-CRP6015N	EUDAMED	IVD General	Active
Ferritin Rapid Test	FER-D02a	EUDAMED	IVD General	Active
Carbon Dioxide Reagent Kit	CO26011Y, CO26012Y, CO26013Y, CO26014Y, CO26015Y, CO26011N, CO26012N, CO26013N, CO26014N, CO26015N	EUDAMED	IVD General	Active
Total Iron-Binding Capacity Reagent Kit	TIBC6011Y, TIBC6012Y, TIBC6013Y, TIBC6014Y, TIBC6015Y, TIBC6011N, TIBC6012N, TIBC6013N, TIBC6014N, TIBC6015N	EUDAMED	IVD General	Active
C-Reactive Protein Reagent Kit	CRP6011Y, CRP6012Y, CRP6013Y, CRP6014Y, CRP6015Y, CRP6011N, CRP6012N, CRP6013N, CRP6014N, CRP6015N	EUDAMED	IVD General	Active
Multi-Drug Test Cup (AMP/COC/BZO/MOP/THC/MDMA) + (CR/SG/pH)	DOA-A67-002	EUDAMED	IVD General	Active
Multi-Drug Rapid Test (Saliva)	DOA-J203a	EUDAMED	IVD General	Active
Dengue IgG/IgM/NS1 Combo Rapid Test	DEAB/DEAG-D35a	EUDAMED	IVD General	Active
Complement 3 Reagent Kit	C36011Y, C36011Y, C36011Y, C36011Y, C36011Y, C36011N, C36011N, C36011N, C36011N, C36011N	EUDAMED	IVD General	Active
Leishmania IgG/IgM Antibody Rapid Test	L-D22a	EUDAMED	IVD General	Active
LSD One Step Lysergic acid diethylamide Test	LSD-A01a	EUDAMED	IVD General	Active
CA242 Cancer Antigen 242 (CLIA)	CA242706-AE10Y, CA242706-AE10N, CA242706-AE20Y, CA242706-AE20N	EUDAMED	IVD General	Active
SP-10 Rapid Test	SP10-K02a	EUDAMED	IVD General	Active
COVID-19/ InfluenzaA+B/RSV Antigen Combo Rapid Test	RV-G45b	EUDAMED	IVD General	Active
Complement 4 Reagent Kit	C46011Y, C46011Y, C46011Y, C46011Y, C46011Y, C46011N, C46011N, C46011N, C46011N, C46011N	EUDAMED	IVD General	Active
THEO Theophylline(CLIA)	THEO706-AE10Y, THEO706-AE10N, THEO706-AE20Y, THEO706-AE20N	EUDAMED	IVD General	Active
Zinc Reagent Kit	Zn6011Y, Zn6012Y, Zn6013Y, Zn6014Y, Zn6015Y, Zn6011N, Zn6012N, Zn6013N, Zn6014N, Zn6015N	EUDAMED	IVD General	Active
Folate (CLIA)	Folate706-AE10Y, Folate706-AE10N, Folate706-AE20Y, Folate706-AE20N	EUDAMED	IVD General	Active
Mult -Drug Test Panel (THC/MDMA/OXY/PCP/COC/MTD/TRA/BAR/BZO/MOP/MET/K2)	DOA-A124-003	EUDAMED	IVD General	Active
CEA Test Kit FIA	CEA-D06a	EUDAMED	IVD General	Active
FT Free Testosterone (CLIA)	FTesto706-AE10Y, FTesto706-AE10N, FTesto706-AE20Y, FTesto706-AE20N	EUDAMED	IVD General	Active
Chikungunya IgG/lgM Antibody Rapid Test	CHIK-D02a	EUDAMED	IVD General	Active
Lactate Dehydrogenase Reagent Kit	LDH6011Y, LDH6012Y, LDH6013Y, LDH6014Y, LDH6015Y, LDH6011N, LDH6012N, LDH6013N, LDH6014N, LDH6015N	EUDAMED	IVD General	Active
Multi-Drug Test Panel (AMP/COC/MET/BZO/BAR/MOP/THC/MDMA/MTD/PCP/OXY/BUP/TRA/K2)	DOA-A144-003	EUDAMED	IVD General	Active
β2-Microglobulin Reagent Kit	β2-MG6011Y, β2-MG6012Y, β2-MG6013Y, β2-MG6014Y, β2-MG6015Y, β2-MG6011N, β2-MG6012N, β2-MG6013N, β2-MG6014N, β2-MG6015N	EUDAMED	IVD General	Active
Dengue NS1 Rapid Test	DEAG-D02b	EUDAMED	IVD General	Active
cTnT Test Kit FIA	CTNT-D06a	EUDAMED	IVD General	Active
β2-MG Test Kit FIA	β2-MG-E06a	EUDAMED	IVD General	Active
H. Pylori Antigen Rapid Test	HP-F02a	EUDAMED	IVD General	Active
Fructosamine Reagent Kit	FMN6011Y, FMN6012Y, FMN6013Y, FMN6014Y, FMN6015Y, FMN6011N, FMN6012N, FMN6013N, FMN6014N, FMN6015N	EUDAMED	IVD General	Active
Cholinesterase Reagent Kit	CHE6011Y, CHE6012Y, CHE6013Y, CHE6014Y, CHE6015Y, CHE6011N, CHE6012N, CHE6013N, CHE6014N, CHE6015N	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

Medunion S.L. ES
SUNGO Europe B.V. NL

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Hangzhou Aichek Medical Technology Co., Ltd. US