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法規編號
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醫材類別
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產品名稱
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等級
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21 CFR Part 862
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Clinical Chemistry and Clinical Toxicology
臨床化學及臨床毒理學
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血糖機 (Blood Glucose Monitoring System)
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II
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呼吸酒精試驗系統 (Breath-alcohol Test System)
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I
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血酮測試系統 (Ketones Test System)
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I
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膽固醇測試系統 (Cholesterol Test System)
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I
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21 CFR Part 864
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Hematology and Pathology
血液學及病理學
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血小板血漿收集容器套組 (Platelet and Plasma Collection Container)
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II
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血球細胞分離器 (Autologous CellPrep Kit)
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II
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血小板濃厚液分離管 (Platelet Concentrate Separator)
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II
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病理影像檢視系統 (Digital Pathology Software)
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II
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21 CFR Part 866
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Immunology and Microbiology
免疫學及微生物學
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人類白血球抗原# (Human Leukocyte Antigen)
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Unclassified
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腫瘤相關抗原免疫試驗系統 (Tumor-associated Antigen Immunological Test System)
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II
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大腸癌檢測試劑 (Carcinoembryonic Antigen (CEA) ImmunoMagnetic Reduction (IMR) Assay)
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II
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C反應蛋白分析卡匣組 (CRP Assay Cartridge Kit)
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II
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21 CFR Part 868
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Anesthesiology
麻醉科學
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手動緊急呼吸器 (Manual Emergency Ventilator)
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II
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噴霧器 (Nebulizer)
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II
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呼吸管路細菌過濾器 (Breathing Circuit Bacterial Filter)
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II
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加熱線呼吸管路組 (Heated Wire Breathing System)
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II
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氣道壓力顯示器 (Airway Pressure Meter)
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II
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智能吸入偵測裝置 (Sensor for pMDI)
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II
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21 CFR Part 870
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Cardiovascular
心臟血管
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深層靜脈栓塞防護器 (Deep Vein Thrombosis Compression Device)
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II
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間歇性氣動加壓治療裝置 (Sequential Compression System)
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II
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血壓計 (Blood Pressure Monitor)
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II
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非侵入式血壓監測系統 (Noninvasive Blood Pressure Measurement System)
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II
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穿戴式心電圖機 (Wearable ECG Recorder)
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II
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心電圖機 (ECG Recorder)
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II
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心電圖分析軟體 (ECG Analysis System)
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II
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導引鞘 (Sheath Introducer)
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II
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導引導線 (Guide Wire)
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II
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電子聽診器 (Electronic Stethoscope)
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II
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血管攝影高壓注射筒 (Disposable Syringe with Accessories for Power Injectors)
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II
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21 CFR Part 872
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Dental
牙科
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排齦材料* (Gingival Retraction Paste)
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Unclassified
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根管充填材料 (Root Canal Filling Materials)
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II
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植牙用人工牙根 (Dental Implant)
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II
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膠原蛋白牙科膜 (Collagen Dental Membrane)
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II
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牙科骨填料 (Dental Bone Graft)
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II
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牙科固定系統 (Bone plate)
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II
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多軸向齒槽骨牽引器 (Alveolar Multi-directional Distractors)
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II
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客製化重建骨板 (Mandibular Reconstruction Plate)
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II
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客製化顏面骨板 (Custom-Made Maxillary Plate System)
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II
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錨定骨釘 (Anchorage Screw)
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II
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氧化鋯瓷塊 (Zirconia Ceramic Block)
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II
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牙科低速手機 (Low Speed Handpiece for Dental)
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I
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牙科電動馬達 (Electric Micromotor Set)
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I
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21 CFR Part 874
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Ear, Nose, and Throat
耳鼻喉科
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矽膠膨體彌補物 (Silicone Implant)
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II
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21 CFR Part 876
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Gastroenterology-Urology
胃腸病及泌尿科學
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腹腔手術取物袋 (Specimen Retrieval System)
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II
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黏膜注射劑 (Submucosal Injection Agent)
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II
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血液透析導管 (Hemodialysis Catheter)
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II
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引流導管組 (Drainage Catheter Set)
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II
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S/I沖吸系列產品 (Suction Irrigation)
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II
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防霧塗料 (Anti-Fog Solution)
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II
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21 CFR Part 878
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General and Plastic Surgery
一般及整形外科手術
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動力式抽吸幫浦 (Powered Suction Pump)
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II
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電燒刀 (Disposable Hand Switching ESU Pencil)
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II
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集脂桶 (Fat Collection System)
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II
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手術燈 (Surgical Light)
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II
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一般外科、整形外科及皮膚科用雷射儀 (Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology)
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II
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外科手術口罩 (Surgical Face Mask)
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II
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手術用隔離衣 (Surgical Gown)
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II
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防護衣 (Isolation Gown)
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II
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負壓傷口敷料 (Negative Pressure Wound Dressing and Accessories)
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II
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親水性創傷覆蓋材 (Hydrophilic Wound Dressing)
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Unclassified
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水膠式創傷敷料 (Hydrogel Wound Dressing)
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Unclassified
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21 CFR Part 880
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General Hospital and Personal Use
一般醫院及個人使用裝置
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皮下單腔針 (Hypodermic Single Lumen Needle)
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II
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針灸針 (Acupuncture Needle)
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II
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放射性藥物注射泵 (Radio-liquid Syringe Pump System)
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II
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腹腔鏡手術器械 (Laparoscopic Instrument)
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II
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中心靜脈導管 (Central Venous Catheter Set)
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II
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蒸氣式滅菌鍋 (Steam Sterilizer)
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II
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耳溫槍 (Ear Thermometer)
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II
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體溫貼片 (Thermometer Patch)
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II
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醫療用空氣清淨設備 (Medical Recirculating Air Cleaner)
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II
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醫療用衣物 (Medical Apparel)
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II
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白血球減除過濾器 (Leukocyte Reduction Filter For Red Blood Cells)
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II
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細胞儲存容器 (Stem Cells Storage Container)
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Unclassified
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病患檢查用手套 (Patient Examination Glove)
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I
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21 CFR Part 882
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Neurological
神經科學
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脊椎手術導航系統 (Surgical Navigation System)
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II
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顱顏導航系統 (Cranial Image Guided Surgery System)
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II
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腦波描記器 (Electroencephalography Amplifier)
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II
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經皮神經電刺激 (Transcutaneous Electrical Nerve Stimulation, TENS)
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II
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中頻向量干擾儀 (Interferential Current Device)
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II
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皮膚光療儀 (Skin Rejuvenating Device)
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II
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針式電擊 (Needle Electrode)
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II
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電極貼片 (Electroconductive Pad)
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II
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21 CFR Part 884
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Obstetrical and Gynecological
婦產科
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子宮輸卵管攝影導管 (Uterine Manipulator/Injector Cannula)
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Unclassified
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陰道子宮托 (Vaginal Pessary)
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II
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子宮內膜吸引式刮除器及其附件(Endometrial Suction Curette and Accessories)
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II
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氣腹針 (Veress Needle)
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II
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精子篩選生物晶片 (Sperm Sorting Chip)
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II
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吸乳器 (Powered Breast Pump)
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II
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21 CFR Part 886
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Ophthalmic
眼科
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軟式隱形眼鏡 (Soft (Hydrophilic) Contact Lens)
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II
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21 CFR Part 888
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Orthopedic
骨科
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生物可吸收性骨釘骨板* (Bioresorbable Bone Plates and Bone Screws)
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II
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骨填補物 (Bone Void Filler)
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II
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骨水泥 (Bone Cement)
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II
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注射式人工骨替代物 (Injectable Bone Graft Substitute)
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II
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骨替代物 (Bone Graft Substitute)
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II
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脊椎內視鏡 (Spine Endoscope)
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II
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脊椎固定系統 (Spinal Fixation System)
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II
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椎間融合器 (PEEK Intervertebral Cage, Interbody Fusion System)
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II
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椎弓螺釘 (Pedicle Screw)
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II
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21 CFR Part 890
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Physical Medicine
物理醫學
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醫療用電動代步車 (Motorized Vehicle For Medical Purposes)
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II
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動力式輪椅 (Powered Wheelchair)
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II
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光療系統 (Phototherapy System)
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II
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遠紅外線燈 (Infrared Lamp)
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II
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雷射生髮帽 (Laser Hair Growth Cap)
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II
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電脈衝肌肉刺激 (Electrical Muscle Stimulation, EMS)
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II
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21 CFR Part 892
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Radiology
放射科
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電腦輔助偵測軟體 (Computer-assisted Detection Device, CAD)
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II
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智慧胸腔X光影像處理系統 (Smart CXR Image Processing System)
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II
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病患定位系統 (Patient Positioning System)
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II
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液晶顯示器 (LCD Monitor)
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II
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─
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─
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甲殼素止血敷料 (Chitosan Gauze)
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Unclassified
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傷口敷料 (Wound Dressing)
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