481 results
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9ms
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Sources: EU EUDAMED, US FDA
BANDAGES AND SPLINTS - OTHER
Device
EU MDR
·
Eu Md Class 1
·Wuxi Emsrun Technology Co., Ltd.·On the market·32 countries
Nantong EgensBiotechnology Co.,Ltd.
Manufacturer
🇨🇳 China·35 Basic UDI-DIs·35 Devices·5 Importers·TÜV SÜD Product Service GmbH, POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A., and POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Jiangsu Mole Bioscience Co., LTD.
Manufacturer
🇨🇳 China·85 Basic UDI-DIs·316 Devices·1 Importer·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
BioDetect（Xiamen）Biotechnology Co., Ltd.
Manufacturer
🇨🇳 China·20 Basic UDI-DIs·20 Devices·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
New Gene (Hangzhou) Bioengineering Co., Ltd.
Manufacturer
🇨🇳 China·2 Basic UDI-DIs·2 Devices·3 Importers·POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Adenosine Deaminase (ADA) Assay Kit (Peroxidase Method)
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shenzhen AmTech Bioengineering Ltd., Inc.·1 device
Multiple Drugs of Abuse Rapid Tests
Device
EU IVDD
·
Eu Ivd Self Testing
·Nantong EgensBiotechnology Co.,Ltd.·No longer on the market
SARS-CoV-2 Antigen Rapid Test kit
Device
EU IVDD
·
Eu Ivd Self Testing
·Nantong EgensBiotechnology Co.,Ltd.·No longer on the market
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·New Gene (Hangzhou) Bioengineering Co., Ltd.·On the market·14 countries
SARS-CoV-2 Antigen Test Cassette
Device
EU IVDD
·
Eu Ivd Self Testing
·Jiangsu Mole Bioscience Co., LTD.·On the market
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·New Gene (Hangzhou) Bioengineering Co., Ltd.·On the market·14 countries
SARS-CoV-2 Antigen Test Cassette
Device
EU IVDD
·
Eu Ivd Self Testing
·Jiangsu Mole Bioscience Co., LTD.·On the market
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·BioDetect（Xiamen）Biotechnology Co., Ltd.·On the market
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·BioDetect（Xiamen）Biotechnology Co., Ltd.·On the market
VIROLOGY - RT & POC - OTHER
Device
EU IVDD
·
Eu Ivd Self Testing
·BioDetect（Xiamen）Biotechnology Co., Ltd.·On the market
Hangzhou Singclean Medical Products Co., Ltd.
Manufacturer
🇨🇳 China·149 Basic UDI-DIs·149 Devices·3 Importers·INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, INSTITUT PRO TESTOVÁNI A CERTIFIKACI, a. s. (INSTITUTE FOR TESTING AND CERTIFICATION) merged with ex-NB 1390, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, DNV Product Assurance AS, UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş., and UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.
Changsha Sinocare Inc.
Manufacturer
🇨🇳 China·67 Basic UDI-DIs·68 Devices·1 Importer·TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, TÜV SÜD Product Service GmbH, and TÜV SÜD Product Service GmbH
Changsha Sinocare Inc.
Manufacturer
🇨🇳 China·1 Importer·TÜV Rheinland LGA Products GmbH
Multiple Drugs of Abuse Rapid Tests
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Nantong EgensBiotechnology Co.,Ltd.·1 device
SARS-CoV-2 Antigen Rapid Test kit
Basic UDI-DI
EU IVDD
·
Eu Ivd Self Testing
·Nantong EgensBiotechnology Co.,Ltd.·1 device