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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 4 of 6

Device	Model / Reference	Registries	Class	Status
25-hydroxy Vitamin D Rapid Test	VD-D02a	EUDAMED	IVD General	Active
Tuberculosis (TB) IgG/IgM Rapid Test	TB-D22a	EUDAMED	IVD General	Active
FER Ferritin (CLIA)	FER706-AE10Y, FER706-AE10N, FER706-AE20Y, FER706-AE20N	EUDAMED	IVD General	Active
Multi-Drug Test Panel (AMP/COC/MET/MOP/THC)	DOA-A54-014	EUDAMED	IVD General	Active
Immunoglobulin M Reagent Kit	IgM6011Y, IgM6012Y, IgM6013Y, IgM6014Y, IgM6015Y, IgM6011N, IgM6012N, IgM6013N, IgM6014N, IgM6015N	EUDAMED	IVD General	Active
Alkaline Phosphatase Reagent Kit	ALP6011Y, ALP6012Y, ALP6013Y, ALP6014Y, ALP6015Y, ALP6011N, ALP6012N, ALP6013N, ALP6014N, ALP6015N	EUDAMED	IVD General	Active
Total Protein Reagent Kit	TP6011Y, TP6012Y, TP6013Y, TP6014Y, TP6015Y, TP6011N, TP6012N, TP6013N, TP6014N, TP6015N	EUDAMED	IVD General	Active
Inorganic Phosphorus Reagent Kit	PHOS6011Y, PHOS6012Y, PHOS6013Y, PHOS6014Y, PHOS6015Y, PHOS6011N, PHOS6012N, PHOS6013N, PHOS6014N, PHOS6015N	EUDAMED	IVD General	Active
FOB-TRF Combo Rapid Test	TSF/FOB-F22a	EUDAMED	IVD General	Active
Aichek	ATSHR706-AE10Y, ATSHR706-AE10N, ATSHR706-AE20Y, ATSHR706-AE20N	EUDAMED	IVD General	Active
Transferrin Rapid Test	TSF-F02a	EUDAMED	IVD General	Active
HSV - 1 IgG Herpes Simplex Virus Type 1 IgG Antibody (CLIA)	HSV1IgG706-AE10Y, HSV1IgG706-AE10N, HSV1IgG706-AE20Y, HSV1IgG706-AE20N	EUDAMED	IVD General	Active
PGI Pepsinogen l (CLIA)	PGI706-AE10Y, PGI706-AE10N, PGI706-AE20Y, PGI706-AE20N	EUDAMED	IVD General	Active
α-L-Fucosidase Reagent Kit	AFU6011Y, AFU6012Y, AFU6013Y, AFU6014Y, AFU6015Y, AFU6011N, AFU6012N, AFU6013N, AFU6014N, AFU6015N	EUDAMED	IVD General	Active
Creatine Kinase MB Isoenzyme Reagent Kit	CK-MB6011Y, CK-MB6012Y, CK-MB6013Y, CK-MB6014Y, CK-MB6015Y, CK-MB6011N, CK-MB6012N, CK-MB6013N, CK-MB6014N, CK-MB6015N	EUDAMED	IVD General	Active
β-HCG Test Kit FIA	β-HCG-D06a	EUDAMED	IVD General	Active
Pancreatic Amylase Reagent Kit	P-AMY6011Y, P-AMY6012Y, P-AMY6013Y, P-AMY6014Y, P-AMY6015Y, P-AMY6011N, P-AMY6012N, P-AMY6013N, P-AMY6014N, P-AMY6015N	EUDAMED	IVD General	Active
Aichek	TT3706-AE10Y, TT3706-AE10N, TT3706-AE20Y, TT3706-AE20N	EUDAMED	IVD General	Active
TM Thrombomodulin (CLIA)	TM706-AE10Y, TM706-AE10N, TM706-AE20Y, TM706-AE20N	EUDAMED	IVD General	Active
Total Bilirubin Reagent Kit	TB-V6011Y, TB-V6012Y, TB-V6013Y, TB-V6014Y, TB-V6015Y, TB-V6011N, TB-V6012N, TB-V6013N, TB-V6014N, TB-V6015N	EUDAMED	IVD General	Active
T3 Test Kit FIA	T3-D06a	EUDAMED	IVD General	Active
CBZ Carbamazepine(CLIA)	CBZ706-AE10Y, CBZ706-AE10N, CBZ706-AE20Y, CBZ706-AE20N	EUDAMED	IVD General	Active
Adenosine Deaminase Reagent Kit	ADA6011Y, ADA6012Y, ADA6013Y, ADA6014Y, ADA6015Y, ADA6011N, ADA6012N, ADA6013N, ADA6014N, ADA6015N	EUDAMED	IVD General	Active
Multi-Drug Test Panel (AMP/COC/MET/OPI/THC)	DOA-A54-005	EUDAMED	IVD General	Active
FOB Test Kit FIA	FOB-F06a	EUDAMED	IVD General	Active
Anti-CCP Anti-Cyclic Citrullinated Peptides Antibody (CLIA)	ACCP706-AE10Y, ACCP706-AE10N, ACCP706-AE20Y, ACCP706-AE20N	EUDAMED	IVD General	Active
COVID-19&Influenza A+B Antigen Rapid Test	COV/FLU-B35a	EUDAMED	IVD General	Active
Multi-Drug Test Panel (COC/THC/MOP/OPI/COT/PCP/BZO/TCA/MDMA/TML/MTD/BAR)	DOA-A124-007	EUDAMED	IVD General	Active
Renin (CLIA)	Renin706-AE10Y, Renin706-AE10N, Renin706-AE20Y, Renin706-AE20N	EUDAMED	IVD General	Active
Multi-Drug Test Panel (THC/AMP/BZO/CBD/MET/PGB/GAB/TML/LSD/COC/OPI/ETG/K2/KET)	DOA-A144-002	EUDAMED	IVD General	Active
PCT Procalcitonin (CLIA)	PCT706-AE10Y, PCT706-AE10N, PCT706-AE20Y, PCT706-AE20N	EUDAMED	IVD General	Active
SAA Rapid Test	SAA-D02a	EUDAMED	IVD General	Active
γ-Glutamyl Transferase Reagent Kit	GGT6011Y, GGT6012Y, GGT6013Y, GGT6014Y, GGT6015Y, GGT6011N, GGT6012N, GGT6013N, GGT6014N, GGT6015N	EUDAMED	IVD General	Active
Chloride Reagent Kit	Cl6011Y, Cl6012Y, Cl6013Y, Cl6014Y, Cl6015Y, Cl6011N, Cl6012N, Cl6013N, Cl6014N, Cl6015N	EUDAMED	IVD General	Active
VD Test Kit FIA	VD-D06a	EUDAMED	IVD General	Active
COD One Step Codeine Test	COD-A01a	EUDAMED	IVD General	Active
PTH Parathyroid Hormone (CLIA)	PTH706-AE10Y, PTH706-AE10N, PTH706-AE20Y, PTH706-AE20N	EUDAMED	IVD General	Active
Rotavirus Antigen Rapid Test	ROTA-F02a	EUDAMED	IVD General	Active
Hp Ab Helicobacter Pylori Antibody (CLIA)	HpAb706-AE10Y, HpAb706-AE10N, HpAb706-AE20Y, HpAb706-AE20N	EUDAMED	IVD General	Active
PDG One Step Ovulation Test	PDG-A01a	EUDAMED	IVD General	Active
Multi-Drug Rapid Test (Saliva) (MOP/MET/COC/AMP/THC/BZO/OXY)	DOA-J73-001	EUDAMED	IVD General	Active
RPOG Test Kit FIA	RPOG-C06a	EUDAMED	IVD General	Active
G-17 Gastrin-17 (CLIA)	G-17706-AE10Y, G-17706-AE10N, G-17706-AE20Y, G-17706-AE20N	EUDAMED	IVD General	Active
Multi-Drug Test Panel (AMP/MET/BZO/MOP/COC/THC/SOMA)	DOA-A74-003	EUDAMED	IVD General	Active
AFP Test Kit FIA	AFP-D06a	EUDAMED	IVD General	Active
GDF-15 Growth Differentiation Factor-15 (CLIA)	GDF-15706-AE10Y, GDF-15706-AE10N, GDF-15706-AE20Y, GDF-15706-AE20N	EUDAMED	IVD General	Active
CA72-4 Cancer Antigen 72-4 (CLIA)	CA72-4706-AE10Y, CA72-4706-AE10N, CA72-4706-AE20Y, CA72-4706-AE20N	EUDAMED	IVD General	Active
Aichek	LH706-AE10Y, LH706-AE10N, LH706-AE20Y, LH706-AE20N	EUDAMED	IVD General	Active
Multi-Drug Test Panel (AMP/BZO/MOP/THC/MET)	DOA-A54-016	EUDAMED	IVD General	Active
MYO Test Kit FIA	MYO-D06a	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

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

Importers

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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