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Suzhou Hokapi Biomedical Engineering Co., Ltd..

China·CN-MF-000013723

Last updated June 8, 2026

Information

Country: China
Address: Building 1: Area A: B1 Floor, West Part of 1F, 2F&4F, Area B: 1F, 3F&4F, Area C: 1F&3F, Building 2: 1F, 2F&4F, Building 7, No.426 Songshan Road, High Tech New District, Suzhou, China
Website: hybiome.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Aileen XU
EUDAMED SRN: CN-MF-000013723
FDA FEI Number: —
DUNS Number: —

Catalogue (114)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
Hokapi™ T4	010305601	EUDAMED	Class B	Active
Hokapi™ Myoglobin	010702001	EUDAMED	Class C	Active
Hokapi™ Vitamin B12	010902601	EUDAMED	Class B	Active
Hokapi™ Beta-Hcg	010409401	EUDAMED	Class C	Active
Hokapi™ Total 25oh Vitamin D	011106001	EUDAMED	Class B	Active
Hokapi™ Vitamin B12	010902001	EUDAMED	Class B	Active
Hokapi™ Sars-Cov-2 Neutralizing Ab	010221101	EUDAMED	IVD General	Active
Hokapi™ Anti-Tpo	010309001	EUDAMED	Class B	Active
Hokapi™ Lh	010402001	EUDAMED	Class B	Active
Hokapi™ B·r·a·h·m·s Pct	011004001	EUDAMED	Class C	Active
Hokapi™ Ae-180	AE18-MA00-0031	EUDAMED	Class A	Active
Hokapi™ Pivka-Ii	010125101	EUDAMED	Class C	Active
Hokapi™ Beta-Hcg	010409101	EUDAMED	Class C	Active
Hokapi™ Ca 72-4	010111601	EUDAMED	Class C	Active
Hokapi™ T4	010305401	EUDAMED	Class B	Active
Automatic Blood Grouping Analyzer	SA20-MA00-0008	EUDAMED	Class A	Active
Hokapi™ Sample Diluent 1	010909201	EUDAMED	Class A	Active
Hokapi™ Cuvette	AE18-FL00-0012	EUDAMED	Class A	Active
Hokapi™ Il-6	011002001	EUDAMED	Class C	Active
Hokapi™ Fsh	010401101	EUDAMED	Class B	Active
Hokapi™ Fsh	010401001	EUDAMED	Class B	Active
Hokapi™ D-Dimer	010714101	EUDAMED	Class C	Active
Hokapi™ Crp	010704601	EUDAMED	Class C	Active
HOKAPI™ SARS-CoV-2 IgG	010219101	EUDAMED	IVD General	Active
Hokapi™ Cuvette	AE20-FL00-0007	EUDAMED	Class A	Active
Hokapi™ Cleaning Solution	010904301	EUDAMED	Class A	Active
Hokapi™ T3	010304401	EUDAMED	Class B	Active
Hokapi™ Fsh	010401601	EUDAMED	Class B	Active
Hokapi™ Sample Diluent	010907201	EUDAMED	Class A	Active
Hokapi™ Substrate Solution 2	010913301	EUDAMED	Class A	Active
Hokapi™ Thyroglobulin	010307401	EUDAMED	Class B	Active
Hokapi™ Sample Diluent 1	0109092601	EUDAMED	Class A	Active
Hokapi™ Amh	010412401	EUDAMED	Class B	Active
Hokapi™ C-Peptide	010601601	EUDAMED	Class C	Active
Hokapi™ Total 25oh Vitamin D	011106601	EUDAMED	Class B	Active
Hokapi™ B·r·a·h·m·s Pct	011004601	EUDAMED	Class C	Active
Hokapi™ Ft3	010301601	EUDAMED	Class B	Active
Hokapi™ Sample Diluent	0109072601	EUDAMED	Class A	Active
Hokapi™ Hcg	010408601	EUDAMED	Class B	Active
Hokapi™ Cea	010101001	EUDAMED	Class C	Active
Hokapi™ Cleaning	010908301	EUDAMED	Class A	Active
Hokapi™ Ft3	010301101	EUDAMED	Class B	Active
Hokapi™ Progesterone	010413101	EUDAMED	Class B	Active
Hokapi™ B·r·a·h·m·s Pct	011004101	EUDAMED	Class C	Active
Hokapi™ Her-2/Neu	010123001	EUDAMED	Class C	Active
Hokapi™ Pg I	010115601	EUDAMED	Class C	Active
Hokapi™ Beta-Hcg	010409001	EUDAMED	Class C	Active
Hokapi™ Hs Troponin I	010713001	EUDAMED	Class C	Active
Hokapi™ Ck Mb	010703001	EUDAMED	Class C	Active
Hokapi™ Myoglobin	010702601	EUDAMED	Class C	Active

Related Companies

Authorised Representatives

Shanghai International Holding Corp. GmbH(Europe) DE

Importers

Not available yet.

Notified Bodies

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Authorities

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