25 results · 26ms · Sources: EU EUDAMED, US FDA

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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

HANGZHOU LAIHE BIOTECH CO.,LTD.

FDA registration
HANGZHOU LAIHE BIOTECH CO.,LTD.·10 products·🇨🇳 China

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

Incubator

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Changsha Yingtai Instrument Co., Ltd·1 device

LDH Rapid Test Kit

Basic UDI-DI
EU IVDD · Eu Ivd General ·Anbio (Xiamen) Biotechnology Co.,Ltd.·1 device

Lactate Dehydrogenase (LDH) Kit (Rate Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Zybio Inc.·1 device

Alanine Aminotransferase Kit (UV-LDH Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shanghai Kehua Bio-engineering Co., Ltd.·1 device

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

COVID-19 and Influenza A/B Antigen Test Kit for self-testing

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

BIOSYNEX FLACON URINE URITOP +2

Basic UDI-DI
EU IVDR · Eu Ivd Class A ·Hangzhou Laihe Biotech Co., Ltd.·1 device

Gonorrhea Antigen Rapid Test Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·1 device

Chlamydia and Gonorrhea Antigen Rapid Test Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·1 device

Chlamydia Antigen Rapid Test Kit

Basic UDI-DI
EU IVDR · Eu Ivd Class C ·Hangzhou Laihe Biotech Co., Ltd.·1 device

Lactate Dehydrogenase (LDH) Assay Kit (Lactate Substrate Method)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device

Myocardial Enzyme Reagent Kit (CK, CK-MB, LDH, α -HBDH)

Basic UDI-DI
EU IVDD · Eu Ivd General ·Changsha Sinocare Inc.·1 device