24 results
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17ms
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Sources: EU EUDAMED, US FDA
Vela Operations Singapore Pte. Ltd.
Manufacturer
🇸🇬 Singapore·75 Basic UDI-DIs·82 Devices·TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, and TÜV Rheinland LGA Products GmbH
Jiangxi Aicare Medical Technology Co.,Ltd
Manufacturer
🇨🇳 China·3 Basic UDI-DIs·3 Devices·TÜV Rheinland LGA Products GmbH and TÜV Rheinland LGA Products GmbH
Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer
🇨🇳 China·212 Basic UDI-DIs·212 Devices·2 Importers·TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., TÜV Rheinland LGA Products GmbH, 3EC International a.s., TÜV Rheinland LGA Products GmbH, TÜV Rheinland LGA Products GmbH, CeCert Sp. z o.o., POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and TÜV Rheinland LGA Products GmbH
Tianjin HUAC Healthcare Technology Co., Ltd.
Manufacturer
🇨🇳 China·3 Basic UDI-DIs·3 Devices·TÜV Rheinland LGA Products GmbH
Sentosa SQ HIV Genotyping Assay (4x16)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Vela Operations Singapore Pte. Ltd.·On the market
Sentosa SQ HCV Genotyping Assay Bundle (4x16)
Device
EU IVDD
·
Eu Ivd Annex 2 List A
·Vela Operations Singapore Pte. Ltd.·On the market
HUAC
Device
EU IVDD
·
Eu Ivd Self Testing
·Tianjin HUAC Healthcare Technology Co., Ltd.·On the market·3 countries
HUAC
Device
EU IVDD
·
Eu Ivd Self Testing
·Tianjin HUAC Healthcare Technology Co., Ltd.·On the market·3 countries
HUAC
Device
EU IVDD
·
Eu Ivd Self Testing
·Tianjin HUAC Healthcare Technology Co., Ltd.·On the market·3 countries
Blood Glucose Meter
Device
EU IVDD
·
Eu Ivd Annex 2 List B
·Jiangxi Aicare Medical Technology Co.,Ltd·On the market·4 countries
SARS-CoV-2 Antigen Rapid Tests for Self-Testing
Device
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·On the market
TÜV Rheinland LGA Products GmbH
Notified body
🇩🇪 Germany·689 Manufacturers·17345 Basic UDI-DIs
Sentosa SQ HIV Genotyping Assay (4x16)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Vela Operations Singapore Pte. Ltd.·1 device
Sentosa SQ HCV Genotyping Assay (4x16)
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List A
·Vela Operations Singapore Pte. Ltd.·1 device
Blood Glucose Meter
Basic UDI-DI
EU IVDD
·
Eu Ivd Annex 2 List B
·Jiangxi Aicare Medical Technology Co.,Ltd·1 device
Digital Pregnancy & Ovulation Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Tianjin HUAC Healthcare Technology Co., Ltd.·1 device
Digital Pregnancy Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Tianjin HUAC Healthcare Technology Co., Ltd.·1 device
Digital Ovulation Test
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Tianjin HUAC Healthcare Technology Co., Ltd.·1 device
SARS-CoV-2 Antigen Rapid Tests for Self-Testing
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Assure Tech. (Hangzhou) Co., Ltd.·1 device
HL 2269091-1
Certificate
IVDD Annex IV Section 4·Jiangxi Aicare Medical Technology Co.,Ltd·TÜV Rheinland LGA Products GmbH·1 Basic UDI-DI