2023-10-30
GaleMed 宜兰工厂取得欧盟医疗器材法规MDR认证
尊敬的客户，
GaleMed历经多年为MDR认证之准备，我们相当荣幸且兴奋地与您分享，GaleMed 宜兰工厂之I、Im、IIa 类产品已取得欧盟医疗器材法规(Medical Device Regulation)认证，证书编号 HZ2100418-1。我们以身为全球呼吸治疗专业领域介面科技的先驱之一，引以自豪，有关更多MDR证书信息，请参考：Link。
崇仁取得之 MDR 认证包含 19 个 EMDN 代码和 GaleMed 产品组合的 1069 个 SKU。此外，亦涵盖了用于呼吸照护的所有一次性与重复性配件与周边组件认证。
MDR 证书涵盖的具体产品范围列表，请参考如下：
- R020101 - STANDARD BREATHING CIRCUITS
- R020102 - COAXIAL BREATHING CIRCUITS
- R020104 - CPAP AND NIV BREATHING CIRCUITS
- R020106 - IPPB CIRCUITS
- R028001 - RESPIRATORY CIRCUITS VALVES
- R028099 - RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
- R030101 - VENTILATION MASKS
- R030102 - AIR/OXYGEN MASKS AND NASAL CANNULAS
- R030103 - AEROSOL THERAPY MASKS AND SYSTEMS
- R030180 – RESPIRATORY MASKS – ACCESSORIES NOT INCLUDED IN OTHER CLASSES
- R030202 – MANUALLY OPERATED VENTILATION BALLOONS
- R030280 - RESPIRATORY BALLONS - ACCESSORIES
- R040102 - ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
- R9001 - RESPIRATORY MOUTHPIECES
- R900902 – INSPIRATORY AND EXPIRATORY FLOW STIMULATORS/RESPIRATORY MUSCLES TRAINERS
- R9080 – RESPIRATORY AND ANESTHESIA DEVICES – ACCESSORIES NOT INCLUDED IN OTHER CLASSES
- V0380 – DEVICES WITH MEASURING FUNCTIONS – ACCESSORIES
- Z121501 – SPIROMETRY INSTRUMENTS
- Z12150199 – SPIROMETRY INSTRUMENTS - OTHER
GaleMed衷心感谢您的坚定支持，使我们持续取得卓越发展。我们将继续透过提供最佳临床解决方案满足客户需求，矢志成为呼吸治疗专业领域的全球领先公司。
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