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Hangzhou Laihe Biotech Co., Ltd.

China·CN-MF-000033566

Last updated June 8, 2026

Information

Country: China
Address: Room 401-406, F1-3, Building 1, No.425 Miaohouwang Road, Xixing Street, Binjiang District,, Hangzhou, Zhejiang, China
Website: lyher.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Shangan SHEN
EUDAMED SRN: CN-MF-000033566
FDA FEI Number: —
DUNS Number: 543330912

Catalogue (24)

Device	Model / Reference	Registries	Class	Status
femometer	FM-IVY-103	FDA UDI	Class I	Active
femometer	FM-IVY-103	FDA UDI	Class I	Active
Lyher	DOA-101	FDA UDI	Class II	Active
femometer	FM-IVY-104	FDA UDI	N/A	Active
Lyher	DTH-101	FDA UDI	Class II	Active
Lyher	303002	FDA UDI	N	Active
Lyher	DTH-102	FDA UDI	Class II	Active
Gonorrhea Antigen Rapid Test Kit	IGO-502	EUDAMED	Class C	Active
Chlamydia and Gonorrhea Antigen Rapid Test Kit	IGC-525	EUDAMED	Class C	Active
LYHER® Oral fluid Multi-Drug Test Kit (Cube)	K240287	FDA 510(k)	Class II	Active
LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)	K232597	FDA 510(k)	Class II	Active
LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)	K232604	FDA 510(k)	Class II	Active
Malaria Antigen Test Kit	303038501, 303036501	EUDAMED	IVD General	Active
COVID-19 and Influenza A/B Antigen Test Kit	303050	EUDAMED	IVD General	Active
Chlamydia Antigen Rapid Test Kit	ICH-502	EUDAMED	Class C	Active
Biosynex Flacon Urine Uritop +2	860693	EUDAMED	Class A	Active
Respiratory Multiple Rapid Test	303021901	EUDAMED	IVD General	Active
Lyher	303051	EUDAMED	IVD devices for self-testing	Active
Dengue NS1/IgG/IgM Test Kit (Colloidal Gold)	303021603, 303035201	EUDAMED	IVD General	Active
Novel Coronavirus (COVID-19) Antigen Test Kit(Colloidal Gold) Code:303034	303034	EUDAMED	IVD General	Active
NovelCoronavirus (COVID-19)AntigenTest Kit(ColloidalGold)for self-testing	303036-05	EUDAMED	IVD devices for self-testing	Active
Respiratory multiple 7 in 1 test kit (FluA/FluB/COVID-19/RSV/Adeno/MP/HMPV)	303041901	EUDAMED	Class B	Active
Novel Coronavirus(COVID-19) Antigen Test Kit(Colloidal Gold)	303035	EUDAMEDFDA UDI	IVD General	Active
Lyher	303021901	EUDAMED	Class B	Active

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Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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