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 

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