Hangzhou Laihe Biotech Co., Ltd.

Manufacturer

🇨🇳 China·6 Basic UDI-DIs·6 Devices·2 Importers·CeCert Sp. z o.o. and TÜV Rheinland LGA Products GmbH

Genabio COVID-19 Rapid Self-Test Kit

FDA registration

HANGZHOU LAIHE BIOTECH CO.,LTD.·1 product·🇨🇳 China

LYHER® Urine Multi-Drug Test Kit(Dipcard)

FDA registration

HANGZHOU LAIHE BIOTECH CO.,LTD.·6 products·🇨🇳 China

LYHER® Urine Marijuana (THC) Test Kit(Cassette)

FDA registration

HANGZHOU LAIHE BIOTECH CO.,LTD.·1 product·🇨🇳 China

Menopause Test Kit

FDA registration

HANGZHOU LAIHE BIOTECH CO.,LTD.·1 product·🇨🇳 China

LYHER Novel Coronavirus (2019-nCoV) IgM/IgG Antibody Combo Test Kit (Colloidal Gold)

FDA registration

HANGZHOU LAIHE BIOTECH CO.,LTD.·1 product·🇨🇳 China

LYHER® Oral fluid Multi-Drug Test Kit (Cube)

FDA registration

HANGZHOU LAIHE BIOTECH CO.,LTD.·6 products·🇨🇳 China

femometer Fertility Tests (Refill)

FDA registration

HANGZHOU LAIHE BIOTECH CO.,LTD.·1 product·🇨🇳 China

femometer

FDA UDI

Hangzhou Laihe Biotech Co.,Ltd.·06972412611836·Test for luteinizing hormone in urine to predic...

femometer

FDA UDI

Hangzhou Laihe Biotech Co.,Ltd.·06972412611843·Test for luteinizing hormone in urine to predic...

CORONAVIRUS - NA REAGENTS [obsolete from 2025-01-01]

Device

EU IVDD · Eu Ivd Self Testing ·Hangzhou Laihe Biotech Co., Ltd.·On the market

LYHER

Device

EU IVDD · Eu Ivd Self Testing ·Hangzhou Laihe Biotech Co., Ltd.·On the market

DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER

Device

EU IVDR · Eu Ivd Class A ·Hangzhou Laihe Biotech Co., Ltd.·On the market·0 countries

GONOCOCCAL ANTIGEN DETECTION

Device

EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·On the market·1 country

STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]

Device

EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·On the market·1 country

Chlamydia Antigen Rapid Test Kit

Device

EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·On the market·3 countries

LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LYHER® Oral fluid Multi-Drug Test Kit (Cube)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette)

FDA 510(k)

FDA Class 2 ·Clinical Toxicology

NovelCoronavirus (COVID-19)AntigenTest Kit(ColloidalGold)for self-testing

Basic UDI-DI

EU IVDD · Eu Ivd Self Testing ·Hangzhou Laihe Biotech Co., Ltd.·1 device