2023-09-29
GaleMed 中國廈門工廠取得歐盟醫療器材法規MDR認證

尊敬的客戶,
今天,我們相當榮幸且興奮地與您分享,GaleMed 中國廈門工廠之所有II 類產品已取得歐盟醫療器材法規(Medical Device Regulation)認證,證書編號HZ2058519-1。我們以身為全球呼吸治療專業領域介面科技的先驅之一,引以自豪,有關更多MDR證書信息,請參考: https://reurl.cc/eWrroL
GaleMed衷心感謝您的堅定支持,使我們持續取得卓越發展。我們將繼續透過提供最佳臨床解決方案滿足客戶需求,矢志成為呼吸治療專業領域的全球領先公司。
崇仁取得之 MDR 認證包含 24 個 EMDN 代碼和 GaleMed 產品組合的 1106 個 SKU。此外,亦涵蓋了用於呼吸照護的所有一次性配件與週邊組件,與擴增取得重複性配件與週邊組件認證。
MDR 證書涵蓋的具體產品範圍列表,請參考如下:
- 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
誠摯感謝您一直以來對GaleMed的支持,期待未來更好地為您服務!
自由時報專題報導:拓展歐洲醫材藍海 崇仁科技取MDR認證
#MDRcertificate #thankyou #respiratorycare #future #medical #leaders #development #share #achievement #team #arabhealth2023 #GaleMed