2023-10-30
GaleMed 宜蘭工廠取得歐盟醫療器材法規MDR認證
尊敬的客戶，
GaleMed歷經多年為MDR認證之準備，我們相當榮幸且興奮地與您分享，GaleMed 宜蘭工廠之I、Im、IIa 類產品已取得歐盟醫療器材法規(Medical Device Regulation)認證，證書編號HZ2100418-1 。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：Link。
崇仁取得之 MDR 認證包含 19 個 EMDN 代碼和 GaleMed 產品組合的 1069 個 SKU。此外，亦涵蓋了用於呼吸照護的所有一次性與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
- 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。
TÜV Rheinland certifies according to EU Medical Devices Regulation – Medical Plastic News
TÜV Rheinland 合作成功案例 - 崇仁科技通過德國萊因MDR認證