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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 2 of 6

Device	Model / Reference	Registries	Class	Status
T4 Test Kit FIA	T4-D06a	EUDAMED	IVD General	Active
Vitamin B12 (CLIA)	VB12706-AE10Y, VB12706-AE10N, VB12706-AE20Y, VB12706-AE20N	EUDAMED	IVD General	Active
SOMA One Step Carisoprodol Test	SOMA-A01a, SOMA-A01b	EUDAMED	IVD General	Active
cTnI/CK-MB/MYO Test Kit FIA	CMC-D06a	EUDAMED	IVD General	Active
Strep B Antigen Rapid Test	STB-K02a	EUDAMED	IVD General	Active
Zika IgG/lgM Antibody Rapid Test	ZIKA-D22a	EUDAMED	IVD General	Active
Multi-Drug Test Panel (AMP/MET/BZO/OPI/COC/THC/SOMA)	DOA-A74-005	EUDAMED	IVD General	Active
LH Test Kit FIA	LH-D06a	EUDAMED	IVD General	Active
PB Phenobarbital(CLIA)	PB706-AE10Y, PB706-AE10N, PB706-AE20Y, PB706-AE20N	EUDAMED	IVD General	Active
FSH One Step Menopause Test	FSH-A02a	EUDAMED	IVD General	Active
cTn-I Cardiac Troponin I (CLIA)	hs-cTnI706-AE10Y, hs-cTnI706-AE10N, hs-cTnI706-AE20Y, hs-cTnI706-AE20N	EUDAMED	IVD General	Active
PIVKA-II Protein Induced by Vitamin K Absence or Antagonist-II (CLIA)	PIVKA-II706-AE10Y, PIVKA-II706-AE10N, PIVKA-II706-AE20Y, PIVKA-II706-AE20N	EUDAMED	IVD General	Active
PCT Test Kit FIA	B-PCT-D06aJ3	EUDAMED	IVD General	Active
PIC Plasmin-α2-Plasmin Inhibitor Complex (CLIA)	PIC706-AE10Y, PIC706-AE10N, PIC706-AE20Y, PIC706-AE20N	EUDAMED	IVD General	Active
Respiratory Syncytial Virus (RSV) Antigen Rapid Test	RSV-B02b	EUDAMED	IVD General	Active
Anti-HAV Hepatitis A Virus Antibody (CLIA)	HAVAb706-AE10Y, HAVAb706-AE10N, HAVAb706-AE20Y, HAVAb706-AE20N	EUDAMED	IVD General	Active
Multi-Drug Test Panel (AMP/BZO/COC/MET/MDMA/ MOP/MTD/PCP/THC/SOMA/K2/K3/ETO)	DOA-A134-002	EUDAMED	IVD General	Active
Multi-Drug Test Cup (AMP/COC/MET/OPI/THC/BZO/BUP/COT/KET/PCP/BAR/MDMA)	DOA-A127-002	EUDAMED	IVD General	Active
Anti-TP Treponema Pallidum Antibody (CLIA)	Anti-TP706-AE10Y, Anti-TP706-AE10N, Anti-TP706-AE20Y, Anti-TP706-AE20N	EUDAMED	IVD General	Active
VPA Valproate(CLIA)	VPA706-AE10Y, VPA706-AE10N, VPA706-AE20Y, VPA706-AE20N	EUDAMED	IVD General	Active
ST2 Test Kit FIA	ST2-D06a	EUDAMED	IVD General	Active
HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx	K233624	FDA 510(k)	Class II	Active
Aichek	SHBG706-AE10Y, SHBG706-AE10N, SHBG706-AE20Y, SHBG706-AE20N	EUDAMED	IVD General	Active
Malaria P.f. Antigen Rapid Test	MAL-D02a	EUDAMED	IVD General	Active
E2 Test Kit FIA	E2-D06a	EUDAMED	IVD General	Active
HSV IgG/IgM Rapid Test	HSV-D02a	EUDAMED	IVD General	Active
Direct Bilirubin Reagent Kit	DB-V6011Y, DB-V6012Y, DB-V6013Y, DB-V6014Y, DB-V6015Y, DB-V6011N, DB-V6012N, DB-V6013N, DB-V6014N, DB-V6015N	EUDAMED	IVD General	Active
Apolipoprotein A1 Reagent Kit	APOA16011Y, APOA16012Y, APOA16013Y, APOA16014Y, APOA16015Y, APOA16011N, APOA16012N, APOA16013N, APOA16014N, APOA16015N	EUDAMED	IVD General	Active
Multi-Drug Test Cup	DOA-A207a	EUDAMED	IVD General	Active
Multi-Drug Test Panel (AMP/COC/OPI/THC)	DOA-A44-009	EUDAMED	IVD General	Active
ASD Androstenedione (CLIA)	ASD706-AE10Y, ASD706-AE10N, ASD706-AE20Y, ASD706-AE20N	EUDAMED	IVD General	Active
Multi-Drug Test Panel (AMP/OPI/PCP/BAR/MTD/TCA/BZO/TRA/COT/COC/MDMA/THC/MET/MOP/ALC)	DOA-A154-001	EUDAMED	IVD General	Active
Salmonella typhi & Salmonellaparatyphi Antigen Combo Rapid Test	STYS-K02a	EUDAMED	IVD General	Active
ETO One Step Etomidate Test	"ETO-A01a, ETO-A04a	EUDAMED	IVD General	Active
Transferrin/FOB/Hb-Hp Combo Rapid Test	TFH-F32a	EUDAMED	IVD General	Active
cTn-T Cardiac Troponin T (CLIA)	hs-cTnT706-AE10Y, hs-cTnT706-AE10N, hs-cTnT706-AE20Y, hs-cTnT706-AE20N	EUDAMED	IVD General	Active
CRP/SAA Test Kit FIA	CRP/SAA-D26a	EUDAMED	IVD General	Active
Cortisol (CLIA)	COR706-AE10Y, COR706-AE10N, COR706-AE20Y, COR706-AE20N	EUDAMED	IVD General	Active
C-P C-Peptide (CLIA)	C-P706-AE10Y, C-P706-AE10N, C-P706-AE20Y, C-P706-AE20N	EUDAMED	IVD General	Active
Multi-Drug Test Panel (AMP/MOP/BZO/MET/THC)	DOA-A54-011	EUDAMED	IVD General	Active
PRL Test Kit FIA	PRL-D06a	EUDAMED	IVD General	Active
ST2 Growth Stimulation Expressed gene 2 (CLIA)	ST2706-AE10Y, ST2706-AE10N, ST2706-AE20Y, ST2706-AE20N	EUDAMED	IVD General	Active
Anti-dsDNA IgG Anti-double-stranded DNA IgG Antibody(CLIA)	anti-dsDNA706-AE10Y, anti-dsDNA706-AE10N, anti-dsDNA706-AE20Y, anti-dsDNA706-AE20N	EUDAMED	IVD General	Active
H-FABP Test Kit FIA	H-FABP-D06a	EUDAMED	IVD General	Active
Cystatin C Reagent Kit	CYS-C6011Y, CYS-C6012Y, CYS-C6013Y, CYS-C6014Y, CYS-C6015Y, CYS-C6011N, CYS-C6012N, CYS-C6013N, CYS-C6014N, CYS-C6015N	EUDAMED	IVD General	Active
D-Dimer (CLIA)	D-D706-AE10Y, D-D706-AE10N, D-D706-AE20Y, D-D706-AE20N	EUDAMED	IVD General	Active
Cortisol Rapid Test	COR-J02a	EUDAMED	IVD General	Active
COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test	RV-B55a	EUDAMED	IVD General	Active
Urea Reagent Kit	UREA6011Y, UREA6012Y, UREA6013Y, UREA6014Y, UREA6015Y, UREA6011N, UREA6012N, UREA6013N, UREA6014N, UREA6015N	EUDAMED	IVD General	Active
Influenza A+B Antigen Rapid Test	FLU-B22b	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

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

Importers

Not available yet.

Notified Bodies

Not available yet.

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