本站大部份資料在 2016 年後就未更新，若資料內無明確標示資料時間，請預設該資料為過時資料並斟酌使用，謝謝
From http://data.fda.gov.tw/frontsite/data/DataAction.do?method=doDetail&infoId=112
| 製造廠名稱 | 製造廠地址 | 登錄號碼 | 登錄品項 | 國別 | 藥商名稱 | 是否在3年有效期間內 | 有效期限 | |
|---|---|---|---|---|---|---|---|---|
| 1937069 | Alphatec Spine Inc. | 5818 El Camino Real, Carlsbad, California, 92008, U.S.A. | QSD5912 | Spinal intervertebral body fixation orthosis | US | 佳鴻醫療器材廠有限公司 | Y | 2017-03-17 |
| 1937070 | Alphatec Spine Inc. | 5818 El Camino Real, Carlsbad, California, 92008, U.S.A. | QSD5912 | Pedicle screw spinal system | US | 佳鴻醫療器材廠有限公司 | Y | 2017-03-17 |
| 1937071 | Biosensors International Pte Ltd. | 21 Kallang Avenue #07-165/171, Singapore 339412, Singapore | QSD5915 | Diagnostic Intravascular | SG | 興東藥品器材有限公司 | Y | 2017-03-14 |
| 1937072 | Biosensors International Pte Ltd. | 21 Kallang Avenue #07-165/171, Singapore 339412, Singapore | QSD5915 | Embolectomy Catheter | SG | 興東藥品器材有限公司 | Y | 2017-03-14 |
| 1937073 | Biosensors International Pte Ltd. | 21 Kallang Avenue #07-165/171, Singapore 339412, Singapore | QSD5915 | Intravascular Catheter | SG | 興東藥品器材有限公司 | Y | 2017-03-14 |
| 1937074 | Biosensors International Pte Ltd. | 21 Kallang Avenue #07-165/171, Singapore 339412, Singapore | QSD5915 | Extravascular Blood Pressure Transducer | SG | 興東藥品器材有限公司 | Y | 2017-03-14 |
| 1937075 | Biosensors International Pte Ltd. | 21 Kallang Avenue #07-165/171, Singapore 339412, Singapore | QSD5915 | Cardiovascular Permanent or Temporary Pacemaker Electrode | SG | 興東藥品器材有限公司 | Y | 2017-03-14 |
| 1937076 | FIAB S.p.A. | Via P. Costoli n.4, 50039 Vicchio(FI), Italy | QSD5918 | “SensiTherm”clinical electronic thermometer | IT | 台灣聖猷達醫療用品有限公司 | Y | 2017-03-17 |
| 1937077 | FIAB S.p.A. | Via P. Costoli n.4, 50039 Vicchio(FI), Italy | QSD5918 | Esophageal stethoscope with electrical conductors等2項。 | IT | 台灣聖猷達醫療用品有限公司 | Y | 2017-03-17 |
| 1937078 | Shanghai Xiangchi Health Products Co.,Ltd. | No.1331Beiyan Road.202179 Chongming Count, Shanghai, China | QSD5921 | Alcohol Pads | CN | 金蒂股份有限公司 | Y | 2017-03-15 |
| 1937079 | Shanghai Xiangchi Health Products Co.,Ltd. | No.1331Beiyan Road.202179 Chongming Count, Shanghai, China | QSD5921 | Medical Apparel | CN | 金蒂股份有限公司 | Y | 2017-03-15 |
| 1937080 | Sewoon Medical Co., Ltd. | 60, Dorim-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do Korea | QSD5924 | Esophageal prosthesis | KR | 互瑞生技股份有限公司 | Y | 2017-03-17 |
| 1937081 | Sewoon Medical Co., Ltd. | 60, Dorim-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do Korea | QSD5924 | Biliary catheter and accessories | KR | 互瑞生技股份有限公司 | Y | 2017-03-17 |
| 1937082 | Sewoon Medical Co., Ltd. | 60, Dorim-gil, Ipjang-myeon, Seobuk-gu, Cheonan-si, Chungcheongnam-do Korea | QSD5924 | Tracheal prosthesis等3項。 | KR | 互瑞生技股份有限公司 | Y | 2017-03-17 |
| 1937083 | Zoll Circulation | 650 Almanor Avenue, Sunnyvale, CA94085 USA | QSD5927 | Thermal Regulation System | US | 鏵甡企業有限公司 | Y | 2017-03-16 |
| 1937084 | Zoll Circulation | 650 Almanor Avenue, Sunnyvale, CA94085 USA | QSD5927 | Thermal Regulation System-accessories | US | 鏵甡企業有限公司 | Y | 2017-03-16 |
| 1937085 | Zoll Circulation | 650 Almanor Avenue, Sunnyvale, CA94085 USA | QSD5927 | Temperature Management Catheter等3項。 | US | 鏵甡企業有限公司 | Y | 2017-03-16 |
| 1937086 | TOITU CO., LTD., Tsunashima Plant | 5-10-3, Tsunashima-Higashi, Kohoku-ku, Yokohama, Kanagawa Prefecture, Japan | QSD5928 | Fetal Phonocardiographic Monitor and Accessories | JP | 長振儀器股份有限公司 | Y | 2017-03-16 |
| 1937087 | TOITU CO., LTD., Tsunashima Plant | 5-10-3, Tsunashima-Higashi, Kohoku-ku, Yokohama, Kanagawa Prefecture, Japan | QSD5928 | Fetal Phonocardiographic Monitor and Accessories | JP | 長振儀器股份有限公司 | Y | 2017-03-16 |
| 1937088 | TOITU CO., LTD., Tsunashima Plant | 5-10-3, Tsunashima-Higashi, Kohoku-ku, Yokohama, Kanagawa Prefecture, Japan | QSD5928 | Perinatal Monitoring System and Accessories | JP | 長振儀器股份有限公司 | Y | 2017-03-16 |
| 1937089 | TOITU CO., LTD., Tsunashima Plant | 5-10-3, Tsunashima-Higashi, Kohoku-ku, Yokohama, Kanagawa Prefecture, Japan | QSD5928 | Perinatal Monitoring System and Accessories | JP | 長振儀器股份有限公司 | Y | 2017-03-16 |
| 1937090 | Boston Scientific Corporation | 5905 Nathan Lane Plymouth, MN 55442, U.S.A. | QSD5929 | Vascular Stent等乙項。 | US | 荷商波士頓科技有限公司台灣分公司 | Y | 2017-03-21 |
| 1937091 | Xuzhou Full Sun Medical Products Ltd. | Binhe Industry Area, Yitang Township, 221316 Pizhou City, China | QSD5931 | Patient Examination Glove | CN | 禾寶醫療器材股份有限公司 | Y | 2017-03-20 |
| 1937092 | Nanoomtech Co., Ltd. | 1F, 970-78 Wolchul-dong, Buk-gu, Gwangju, 500-460, Korea | QSD5933 | Automated External Defibrillators等乙項。 | KR | 凱樂斯有限公司 | Y | 2017-03-22 |
| 1937093 | CEFLA S.C.-CEFLA DENTAL GROUP | VIA BICOCCA 14/C- 40026 IMOLA (BO), ITALY | QSD5935 | Extraoral Source X-ray System | IT | 荷茂生醫科技股份有限公司 | Y | 2017-03-20 |
| 1937094 | Dentis Co., Ltd. | 99, Seongseoseo-ro, Dalseo-Gu, Daegu, Korea | QSD5936 | Endosseous implant | KR | 登特司科技有限公司 | Y | 2017-03-22 |
| 1937095 | Dentis Co., Ltd. | 99, Seongseoseo-ro, Dalseo-Gu, Daegu, Korea | QSD5936 | Subperiosteal Implant Material | KR | 登特司科技有限公司 | Y | 2017-03-22 |
| 1937096 | Ambu Limited | No. C Warehouse & Process Complex Building, Xiang Yu F. T. Z., 361006,Xiamen City, Fujian Province, China | QSD5940 | Tracheal Tube | CN | 春菖貿易有限公司 | Y | 2017-04-11 |
| 1937097 | Ambu Limited | No. C Warehouse & Process Complex Building, Xiang Yu F. T. Z., 361006,Xiamen City, Fujian Province, China | QSD5940 | Oxygen Mask | CN | 春菖貿易有限公司 | Y | 2017-04-11 |
| 1937098 | Ambu Limited | No. C Warehouse & Process Complex Building, Xiang Yu F. T. Z., 361006,Xiamen City, Fujian Province, China | QSD5940 | Anesthetic Gas Mask | CN | 春菖貿易有限公司 | Y | 2017-04-11 |
| 1937099 | Ambu Limited | No. C Warehouse & Process Complex Building, Xiang Yu F. T. Z., 361006,Xiamen City, Fujian Province, China | QSD5940 | Incentive Spirometer | CN | 春菖貿易有限公司 | Y | 2017-04-11 |
| 1937100 | Ambu Limited | No. C Warehouse & Process Complex Building, Xiang Yu F. T. Z., 361006,Xiamen City, Fujian Province, China | QSD5940 | Truncal Orthosis | CN | 春菖貿易有限公司 | Y | 2017-04-11 |
| 1937101 | Ambu Limited | No. C Warehouse & Process Complex Building, Xiang Yu F. T. Z., 361006,Xiamen City, Fujian Province, China | QSD5940 | Positive End Expiratory Pressure Breathing Attachment | CN | 春菖貿易有限公司 | Y | 2017-04-11 |
| 1937102 | Greatbatch Medical | 2300 Berkshire Lane North, Minneapolis, MN 55441, USA | QSD5948 | Catheter Introducer | US | 六霖企業有限公司 | Y | 2017-04-12 |
| 1937103 | Cousin Biotech S.A.S | Allee des Roses-59117 Wervicq-Sud-France | QSD5950 | Intervertebral Devices等乙項。 | FR | 美敦力醫療產品股份有限公司 | Y | 2017-03-14 |
| 1937104 | Bio-Rad Laboratories (Diaqnostics Group) | 9500 Jeronimo Road, Irvine, CA 92618, U.S.A. | QSD5955 | Calibrators | US | 美商貝克曼庫爾特有限公司台灣分公司 | Y | 2017-03-27 |
| 1937105 | bioMérieux Italia S.p.A. | Via di Campigliano, 58-Bagno a Ripoli 50012, FIRENZE, Italy | QSD5956 | Discrete Photometric Chemistry Analyzer for Clinical Use | IT | 香港商生物梅里埃有限公司台灣分公司 | Y | 2017-03-27 |
| 1937106 | bioMérieux Italia S.p.A. | Via di Campigliano, 58-Bagno a Ripoli 50012, FIRENZE, Italy | QSD5956 | Micro Chemistry Analyzer for Clinical Use | IT | 香港商生物梅里埃有限公司台灣分公司 | Y | 2017-03-27 |
| 1937107 | bioMérieux Italia S.p.A. | Via di Campigliano, 58-Bagno a Ripoli 50012, FIRENZE, Italy | QSD5956 | Colorimeter, Photometer, or Spectrophotometer for Clinical Use | IT | 香港商生物梅里埃有限公司台灣分公司 | Y | 2017-03-27 |
| 1937108 | Interlab SRL | Via Rina Monti, 26-00155 Roma (RM), Italy | QSD5957 | Electrophoresis Apparatus for Clinical Use | IT | 美艾利爾健康股份有限公司 | Y | 2017-03-27 |
| 1937109 | Interlab SRL | Via Rina Monti, 26-00155 Roma (RM), Italy | QSD5957 | Immunoelectrophoresis Equipment | IT | 美艾利爾健康股份有限公司 | Y | 2017-03-27 |
| 1937110 | Interlab SRL | Via Rina Monti, 26-00155 Roma (RM), Italy | QSD5957 | Microtiter Diluting and Dispensing Device | IT | 美艾利爾健康股份有限公司 | Y | 2017-03-27 |
| 1937111 | Interlab SRL | Via Rina Monti, 26-00155 Roma (RM), Italy | QSD5957 | Quality Control Material (Assayed and Unassayed) | IT | 美艾利爾健康股份有限公司 | Y | 2017-03-27 |
| 1937112 | Interlab SRL | Via Rina Monti, 26-00155 Roma (RM), Italy | QSD5957 | Immunoglobulin (Light Chain Specific) Immunological Test System | IT | 美艾利爾健康股份有限公司 | Y | 2017-03-27 |
| 1937113 | Interlab SRL | Via Rina Monti, 26-00155 Roma (RM), Italy | QSD5957 | Beta-globulin Immunological Test System | IT | 美艾利爾健康股份有限公司 | Y | 2017-03-27 |
| 1937114 | Interlab SRL | Via Rina Monti, 26-00155 Roma (RM), Italy | QSD5957 | Dye and Chemical Solution Stains | IT | 美艾利爾健康股份有限公司 | Y | 2017-03-27 |
| 1937115 | Interlab SRL | Via Rina Monti, 26-00155 Roma (RM), Italy | QSD5957 | Protein (Fractionation) Test Systems | IT | 美艾利爾健康股份有限公司 | Y | 2017-03-27 |
| 1937116 | Interlab SRL | Via Rina Monti, 26-00155 Roma (RM), Italy | QSD5957 | Electrophoretic Hemoglobin Analysis System | IT | 美艾利爾健康股份有限公司 | Y | 2017-03-27 |
| 1937117 | Interlab SRL | Via Rina Monti, 26-00155 Roma (RM), Italy | QSD5957 | Immunoglobulins A, G, M, D, and E Immunological Test System | IT | 美艾利爾健康股份有限公司 | Y | 2017-03-27 |
| 1937118 | Interlab SRL | Via Rina Monti, 26-00155 Roma (RM), Italy | QSD5957 | Lipoprotein Test System | IT | 美艾利爾健康股份有限公司 | Y | 2017-03-27 |