Is this your brand? Sign in to claim ownership.

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 2 of 3

Device	Model / Reference	Registries	Class	Status
Hokapi™ Ck Mb	010703101	EUDAMED	Class C	Active
Hokapi™ T3	010304001	EUDAMED	Class B	Active
Hokapi™ Pivka-Ii	010125601	EUDAMED	Class C	Active
Hokapi™ C-Peptide	010602001	EUDAMED	Class C	Active
Hokapi™ Scc	010113001	EUDAMED	Class C	Active
Hokapi™ Hs Troponin I	010713101	EUDAMED	Class C	Active
Hokapi™ Pivka-Ii	010125401	EUDAMED	Class C	Active
Hokapi™ Tsh	010303401	EUDAMED	Class B	Active
HOKAPI™ SARS-CoV-2 IgM	010220101	EUDAMED	IVD General	Active
Hokapi™ Amh	010412101	EUDAMED	Class B	Active
Hokapi™ Estradiol	010414401	EUDAMED	Class B	Active
Hokapi™ T4	010305101	EUDAMED	Class B	Active
Hokapi™ Prolactin	010403001	EUDAMED	Class B	Active
Hokapi™ Fsh	010401401	EUDAMED	Class B	Active
Hokapi™ Gastrin-17	010124401	EUDAMED	Class B	Active
Hokapi™ Pg I	010115001	EUDAMED	Class C	Active
Hokapi™ Sample Diluent	0109072001	EUDAMED	Class A	Active
Hokapi™ D-Dimer	010714601	EUDAMED	Class C	Active
Hokapi™ Anti-Tpo	010309401	EUDAMED	Class B	Active
Hokapi™ Beta-Hcg	010409601	EUDAMED	Class C	Active
Hokapi™ Progesterone	010413401	EUDAMED	Class B	Active
Hokapi™ Ca 15-3	010107101	EUDAMED	Class C	Active
Hokapi™ Progrp	010122001	EUDAMED	Class C	Active
Hokapi™ Ca 125	010105101	EUDAMED	Class C	Active
Hokapi™ Ae-200	AE20-MA00-0002	EUDAMED	Class A	Active
Hokapi™ Anti-Tpo	010305101	EUDAMED	Class B	Active
Hokapi™ Crp	010704001	EUDAMED	Class C	Active
Hokapi™ Ca 19-9	010106001	EUDAMED	Class C	Active
Hokapi™ Nt-Probnp	010706001	EUDAMED	Class C	Active
Hokapi™ Lh	010402401	EUDAMED	Class B	Active
Hokapi™ Insulin	010601001	EUDAMED	Class C	Active
Hokapi™ Fpsa	010104601	EUDAMED	Class C	Active
Hokapi™ Lh	010402101	EUDAMED	Class B	Active
Hokapi™ Estradiol	010414001	EUDAMED	Class B	Active
Hokapi™ Anti-Tg	010308601	EUDAMED	Class B	Active
Hokapi™ Psa	010103601	EUDAMED	Class C	Active
Hokapi™ Thyroglobulin	010307001	EUDAMED	Class B	Active
Hokapi™ Pg Ii	010116601	EUDAMED	Class C	Active
Hokapi™ Cyfra 21-1	010110101	EUDAMED	Class C	Active
Hokapi™ Nse	010112001	EUDAMED	Class C	Active
Hokapi™ Afp	010102601	EUDAMED	Class C	Active
Hokapi™ Cea	010101101	EUDAMED	Class C	Active
Hokapi™ Ca 242	010109601	EUDAMED	Class C	Active
Hokapi™ Pth	011102101	EUDAMED	Class B	Active
Hokapi™ Ft3	010301401	EUDAMED	Class B	Active
Hokapi™ Tsh	010303101	EUDAMED	Class B	Active
Hokapi™ Thyroglobulin	010307101	EUDAMED	Class B	Active
Hokapi™ Gastrin-17	010124601	EUDAMED	Class B	Active
Hokapi™ Ca 50	010108601	EUDAMED	Class C	Active
Hokapi™ Ca 72-4	010111101	EUDAMED	Class C	Active

Related Companies

Authorised Representatives

Shanghai International Holding Corp. GmbH(Europe) DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.