2023-09-29
GaleMed 中国厦门工厂取得欧盟医疗器材法规MDR认证

尊敬的客户,
今天,我们相当荣幸且兴奋地与您分享,GaleMed 中国厦门工厂的所有II 类产品已获得欧盟医疗器材法规(Medical Device Regulation)认证,证书编号HZ2058519-1。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: https://reurl.cc/eWrroL
GaleMed衷心感谢您的坚定支持,使我们持续取得卓越发展。我们将继续通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。
崇仁取得的 MDR 认证包含 24 个 EMDN 代码和 GaleMed 产品组合的 1106 个 SKU。此外,亦涵盖了用于呼吸照护的所有一次性配件与周边设备,与扩增取得重复性配件与周边设备认证。
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
- R020199 - BREATHING CIRCUITS AND KITS - OTHER
- R020201 - FIXED CATHETER MOUNTS
- R020202 - MOBILE CATHETER MOUNTS
- R020301 - RESPIRATORY CIRCUITS CONNECTION PIPES
- R020302 - RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS
- R020399 - ANESTHESIA AND RESUSCITATION CONNECTORS - OTHER
- R028001 - RESPIRATORY CIRCUITS VALVES
- R028003 - RESPIRATORY CIRCUITS WATER TRAPS
- 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
- R030202 - MANUALLY OPERATED VENTILATION BALLOONS
- R030280 - RESPIRATORY BALLONS - ACCESSORIES
- R040101 - ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS
- R040102 - ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS
- R040201 - TRACHEOSTOMY HUMIDIFIERS
- R060280 - HUMIDIFICATION SYSTEMS - ACCESSORIES
- R0680 - NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES
- R9001 - RESPIRATORY MOUTHPIECES
感谢您一直以来对GaleMed的支持,期待未来能更好地为您服务!
自由时报专题报导:拓展欧洲医材蓝海 崇仁科技取MDR认证
#MDRcertificate #thankyou #respiratorycare #future #medical #leaders #development #share #achievement #team #arabhealth2023 #GaleMed