Waters announces medical device approval in China for its liquid chromatography system

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Waters announces medical device approval in China for its liquid chromatography system

机译：沃特世宣布其液相色谱系统在中国获得医疗器械批准

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US-based analytical technologies major, Waters Corporation, has announced that the Chinese Food and Drug Administration (CFDA) has approved the registration of its 'Acquity UPLC TQD' system for legal promotion and sale in China as a medical device for routine diagnostic applications and neonatal metabolites diseases screening.

机译：总部位于美国的分析技术专业公司沃特世公司（Waters Corporation）宣布，中国食品药品监督管理局（CFDA）已批准其“ Acquity UPLC TQD”系统在中国的合法推广和销售注册，作为常规诊断应用中的医疗设备，新生儿代谢物疾病的筛查。

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《Chemical Weekly》 |2014年第45期|共1页
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1. Waters announces medical device approval in China for its liquid chromatography system [J] . Chemical Weekly group Chemical Weekly . 2014,第45期

机译：沃特世宣布其液相色谱系统在中国获得医疗器械批准
2. Comparison of high-performance liquid chromatography and supercritical fluid chromatography using evaporative light scattering detection for the determination of plasticizers in medical devices [J] . Lecoeur Marie, Decaudin Bertrand, Guillotin Yoann, Journal of chromatography, A: Including electrophoresis and other separation methods . 2015,第Null期

机译：高效液相色谱法和超临界流体色谱法在蒸发光散射检测中用于测定医疗器械中增塑剂的比较
3. Comparison of high-performance liquid chromatography and supercritical fluid chromatography using evaporative light scattering detection for the determination of plasticizers in medical devices [J] . Lecoeur Marie, Decaudin Bertrand, Guillotin Yoann, Journal of chromatography, A: Including electrophoresis and other separation methods . 2015,第Null期

机译：高效液相色谱法和超临界流体色谱法在蒸发光散射检测中用于测定医疗器械中增塑剂的比较
4. Medical Device Approval Process in China since the Introduction of the China Food and Drug Administration [C] . Tobias Lueddemann, Diqing Chang, Sadik Sahin, IEEE Symposium on Product Compliance Engineering . 2016

机译：中国食品和药物管理局引进以来中国医疗器械批准过程
5. Medical Device Recalls: The Need for an Updated Protocol in the 510k Approval Process for Medical Device Safety and Efficacy [D] . Boles, Kelly D. 2020

机译：医疗设备召回：在510K批准过程中需要更新的协议，用于医疗器械安全性和疗效
6. Pharmacokinetic Studies of Chinese Medicinal Herbs Using an Automated Blood Sampling System and Liquid Chromatography-mass Spectrometry [O] . Yu-Tse Wu, Ming-Tsang Wu, Chia-Chun Lin, 2012

机译：使用自动血液采样系统和液相色谱-质谱法研究中草药的药代动力学
7. Report drawn up on behalf of the Committee on Economic and Monetary Affairs on proposals from the Commission of the European Communities to the Council on the elimination of technical barriers to trade in particular, proposals for directives on the approximation of laws of theMember States relating to:safety belts and restraint systems and head restraints of seats of motorvehicles (Doe. 464/74);headlights for motor vehicles emitting an asymmetrical passing beam or adriving beam or both, and to incandescent electric lamps for suchheadlights (Doe. 452/74);side lights, rear lights and stop lights for motor vehicles and their trailers(Doe. 457/74);the rear registration-plate illuminating device of motor vehicles and theirtrailers (Doe. 450/74);towing hooks on motor vehicles (Doe. 462/74);the roll-over protection structures of wheeled agricultural or forestrytractors (Doe. 456/74);the type-approval of motorcycles (Doe. 463/74 );alcoholometers and hydrometers for alcohol and alcohol tables(Doe. 406/74);electromedical equipment and medical X-ray equipment operating at 10to 400 kV (Doe. 453/74);common provisions for constructional plant and equipment; themeasurement of the sound level of constructional plant and equipment;the permissible sound level for pneumatic concrete-breakers andjackhammers (Doe. 454/74); 'appliances using gaseous fuels, safety and control devices for theseappliances and methods for inspecting these appliances and appliancesusing gaseous fuels for the instantaneous production of hot water forsanitary purposes (Doe. 459/74). Working Documents 1974-1975, Document 517/74, 10 March 1975 [O] . 1975

机译：代表经济和货币事务委员会就欧洲共同体委员会向理事会提出的关于消除贸易技术壁垒的建议提出的报告，关于近似法律的指示的提案成员国涉及：安全带和约束系统以及电动机座椅的头枕车辆（Doe.464 / 74）;用于发出不对称通过光束或a的机动车辆的前灯驱动光束或两者，以及用于此类的白炽电灯头灯（Doe.452 / 74）;汽车及其拖车的侧灯，尾灯和刹车灯（Doe.457 / 74）;机动车后置板照明装置及其机动车拖车（Doe.450 / 74）;机动车辆上的牵引钩（Doe.462 / 74）;轮式农业或林业的翻车保护结构拖拉机（Doe.456 / 74）;摩托车的型式认可（Doe.463 / 74）;用于酒精和酒精表的酒精计和比重计（Doe.406 / 74）;电子医疗设备和医疗X射线设备运行在10到400 kV（Doe.453 / 74）;建筑工厂和设备的共同规定;该测量建筑工厂和设备的声级;气动混凝土破碎机允许的声级手提钻（Doe.454 / 74）; “使用气体燃料的设备，这些设备的安全和控制装置用于检查这些器具和器具的器具和方法使用气态燃料瞬间生产热水卫生用途（Doe.459 / 74）。工作文件1974-1975，文件517/74，1975年3月10日
8. The Microdetermination of Mercury Species in Natural Water Systems by Liquid Chromatography. [R] . baltisberger,richard j. 1976

机译：液相色谱法测定天然水体系中的汞物种。

Waters announces medical device approval in China for its liquid chromatography system

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