27 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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Malaria P.v Antigen Rapid Test
Device
EU IVDD
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Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
Malaria P.f./P.v. Rapid Test Device
Device
EU IVDD
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Eu Ivd General
·Hangzhou Realy Tech Co.,Ltd.·On the market
Malaria P.f/P.v Antigen Rapid Test
Device
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·On the market
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
Malaria P.f ＆P.v Rapid Test (Whole Blood)
Device
EU IVDD
·
Eu Ivd General
·Sejoy Biomedical Co., Ltd.·On the market
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare Carestation 650c A1, Model/REF Number 1012-9655-200. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
Malaria P.v Antigen Rapid Test
Basic UDI-DI
EU IVDD
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Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
Malaria P.f P.v Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Sejoy Biomedical Co., Ltd.·1 device
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
NANNING VV DENTAL CO., LTD.
FDA registration
NANNING VV DENTAL CO., LTD.·1 product·🇨🇳 China
Malaria P.f/P.v Antigen Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shanghai Zymetas Medtech Co., Ltd·1 device
Malaria P.f/P.v Antigen Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shanghai Zymetas Medtech Co., Ltd·1 device
Malaria P.f/P.v Antigen Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Shanghai Zymetas Medtech Co., Ltd·1 device
Malaria P.f/P.v Antigen Rapid Test
Basic UDI-DI
EU IVDD
·
Eu Ivd General
·Xiamen Biotime Biotechnology Co., Ltd.·1 device
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
FDA Enforcement
Class I
·Ongoing·GE Medical Systems China Co., Ltd.·May 7, 2025
Tigsun Flu/RSV/AdV/PIV Combo Antigen Rapid Test
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Beijing Tigsun Diagnostics Co., Ltd.·9 devices