25 results
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26ms
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Sources: EU EUDAMED, US FDA
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Country: China
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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
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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