7 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Country: China
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APPS-HEALTH01
FDA 510(k)
FDA Class 2
·Cardiovascular
GE Healthcare Versana Ultrasound Systems, sold under the following names and Model/Catalog Numbers: 1) Versana Premier R3 VS, Model/Catalog Number 5938558; 2) Versana Premier R3 VA, Model/Catalog Number 5938559; 3) Versana Premier Lotus 4PP, Model/Catalog Number 5938560; 4) Versana Premier Lotus 5PP, Model/Catalog Number 5938561; 5) Versana Premier R3 VA Vet, Model/Catalog Number 5946387; 6) Versana Premier R3 VS Vet, Model/Catalog Number 5946481. 7) Versana Premier R3 Expert, Model/Catalog Number 5946950; 8) Versana Premier R3, Model/Catalog Number 5946951; 9) Versana Premier R3 Pro, Model/Catalog Number 5946952; 10) Versana Premier R3 Elite, Model/Catalog Number 5946953; 11) Versana Premier R3 Plus, Model/Catalog Number 5946954; 12) Versana Premier R3 Ultra, Model/Catalog Number 5946955; 13) Versana Premier R3 Max, Model/Catalog Number 5946956; 14) Versana Premier R3 Super, Model/Catalog Number 5946957; 15) Versana Premier R3 VS India, Model/Catalog Number 5948398; 16) Versana Premier R3 VA India, Model/Catalog Number 5948399; diagnostic ultrasound system
FDA Enforcement
Class II
·Ongoing·GE Medical Systems China Co., Ltd.·July 2, 2025
iBreathe APP
Basic UDI-DI
EU MDR
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Eu Md Class 1
·FEELLIFE HEALTH INC.·1 device
ECG App
Basic UDI-DI
EU MDR
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Eu Md Class 2b
·Huawei Device Co., Ltd.·1 device
Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK
FDA 510(k)
FDA Class 2
·Cardiovascular
Continuous Glucose Monitoring System APP
Basic UDI-DI
EU MDR
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Eu Md Class 2b
·Changsha Sinocare Inc.·1 device
High Sensitivity C-reactive Protein Kit（Particle-enhanced Immunoturbidimetric Assay Method）、HS-CRP Calibrator
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·7 devices