6 results
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24ms
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Sources: EU EUDAMED, US FDA
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Country: China
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JW Medical Systems Ltd.
Manufacturer
🇨🇳 China
LigaSure Curved Jaw, Open Sealer/Divider Electrode, LigaSure Curved Jaw Open Reusable Clamp
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Laser Speckle Imaging System (RFLSI CZW)
FDA 510(k)
FDA Class 2
·Cardiovascular
MR Serum Standard、MR Urine Standard、MR Urine Quality Control
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI)
FDA Enforcement
Class II
·Ongoing·Changchun Wancheng Bio-Electron Co., Ltd.·February 11, 2026
Immunoassay Multi Control
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices