| 序號 | 許可證字號 | 發證日期 | 中文品名 | 英文品名 | 分類分級代碼 |
|
1
| 衛署醫器輸壹第006963號 | 2008/8/4 | 奎可視披衣菌測定試劑 | QuickVue Chlamydia Test | C.3120 |
|
2
| 衛署醫器輸壹第006965號 | 2008/8/4 | 奎可視流行性感冒病毒A型和B型測定試劑 | QuickVue Influenza A+B Test | C.3330 |
|
3
| 衛署醫器輸壹第006964號 | 2008/8/4 | 奎可視鏈球菌A群測定試劑 | QuickVue Strep A Test | C.3740 |
|
4
| 衛署醫器輸壹第006962號 | 2008/8/4 | 奎可視幽門螺旋桿菌測定試劑 | QuickVue H.pylori gII Test | C.0003 |
|
5
| 衛署醫器輸第019121號 | 2008/7/16 | “泰爾茂”泰爾鍶採血裝置第二代 | “Terumo”TERUSYS S Apheresis machine | I.4800* |
|
6
| 衛署醫器輸第019119號 | 2008/7/16 | “奎爾”牙科斷層X光機 | “QR”New Tom VG X-Ray | F.1800* |
|
7
| 衛署醫器輸第019115號 | 2008/7/14 | “曲克”括約肌切開刀 | “Cook”Sphincterotomes | H.4300* |
|
8
| 衛署醫器輸第019105號 | 2008/7/11 | “優施西”一次性端對端吻合器 | “USSC”DST Series EEA OrVil Single-Use Staplers | I.4750* |
|
9
| 衛署醫器製壹第002191號 | 2008/6/30 | “十全”胎兒聽診器 (未滅菌) | “Utmost Perfect”Fetal stethoscope (Non-sterile) | L.2900 |
|
10
| 衛署醫器輸壹第006849號 | 2008/6/30 | “塞夫士金”手術用手套 (未滅菌, 不含粉) | “Safeskin”Surgeon's Glove (non-sterile, powder free) | I.4460 |
|
11
| 衛署醫器輸壹第006850號 | 2008/6/30 | “沃克”診斷用聚光鏡片 (未滅菌) | “Volk” Diagnostic condensing lens (Non-Sterile) | M.1380 |
|
12
| 衛署醫器製壹第002192號 | 2008/6/30 | “十全”熱及濕氣凝結器(人工鼻) (未滅菌) | “Utmost Perfect” Heat and moisture condenser (artificial nose) (Non-Sterile) | D.5375 |
|
13
| 衛署醫器輸壹第006848號 | 2008/6/30 | “葵斯”假牙襯墊 (未滅菌) | “Queisser”Protefix Denture Cushions (Non-sterile) | F.3540 |
|
14
| 衛署醫器製壹第002188號 | 2008/6/30 | “長宇”體外肢體義肢用組件(未滅菌) | “Chang-Yu”External Limb Prosthetic Component (non-sterile) | O.3420 |
|
15
| 衛署醫器製壹第002189號 | 2008/6/30 | “長宇”肢體裝具 (未滅菌) | “Chang-Yu”Limb Orthosis (non-sterile) | O.3475 |
|
16
| 衛署醫器製壹第002190號 | 2008/6/30 | “太平洋”引流管(滅菌) | “PAHSCO”Drain (sterile) | I.4200 |
|
17
| 衛署醫器輸第019088號 | 2008/6/30 | “泰爾茂”泰爾鍶採血套第二代 | “Terumo” Terusys Apheresis Set S | B.9100 |
|
18
| 衛署醫器輸壹第006843號 | 2008/6/27 | "愛根" 動力工具系統組 (未滅菌) | "AYGUN" POWER SYSTEM (Non-Sterile) | I.4820 |
|
19
| 衛署醫器輸壹第006842號 | 2008/6/27 | 生研三酸甘油脂試劑-EX | TG-EX "SEIKEN" | A.1705 |
|
20
| 衛署醫器製壹第002187號 | 2008/6/27 | “重光”體外肢體義肢用組件 (未滅菌) | “Chong Guang” External limb prosthetic component (non-sterile) | O.3420 |
|
21
| 衛署醫器輸壹第006844號 | 2008/6/27 | “阿蘇”彈性伸縮絆 (未滅菌) | “ASO” ELASTIC BANDAGE (NON-STERILE) | J.5240 |
|
22
| 衛署醫器輸壹第006845號 | 2008/6/27 | “思泰瑞”超音波洗淨機 (未滅菌) | “Steris”Ultrasonic cleaner (Non-Sterile) | J.6150 |
|
23
| 衛署醫器輸壹第006847號 | 2008/6/27 | “貝特爾”動力式治療檯 (未滅菌) | “BTL” POWERED TABLE (Non-Sterile) | O.3760 |
|
24
| 衛署醫器輸第019394號 | 2008/6/27 | “依免可”品質對照品管液 | “Immucor”WB corQC | B.9650 |
|
25
| 衛署醫器輸第019396號 | 2008/6/27 | 茉爾驗孕測試系列 | One Step HCG Test System | A.1155 |
|
26
| 衛署醫器輸第019397號 | 2008/6/27 | 羅氏 ”達可” B型肝炎病毒核酸檢驗試劑套組 | COBAS TaqMan HBV Test | B.4020 |
|
27
| 衛署醫器陸輸第000347號 | 2008/6/27 | 英派康拋棄式塑膠真空採血管(綠色管:肝素鋰+分離膠) | INSEPACK ST Series Disposable Vacuum Blood Collection Tube (Green Tube with Li-Heparin and Gel) | A.1675 |
|
28
| 衛署醫器輸壹第006846號 | 2008/6/27 | “思泰瑞”手術床及零配件(未滅菌) | “Steris”Surgical Table and Accessory (Non-Sterile) | I.4960 |
|
29
| 衛署醫器輸壹第006841號 | 2008/6/26 | "必帝"陰道炎病原體鑑定試劑 | "BD"Affirm VPIII Microbial Identification Test | C.2660 |
|
30
| 衛署醫器輸壹第006840號 | 2008/6/26 | “沙登”牙菌斑顯示劑(未滅菌) | “Sultan”Disclosing Solution (Non-Sterile) | F.4565 |
|
31
| 衛署醫器輸壹第006839號 | 2008/6/26 | “葵斯”假牙黏著劑(未滅菌) | “Queisser”Protefix Adhesive Cream (Non-sterile) | F.3490 |
|
32
| 衛署醫器輸壹第006838號 | 2008/6/26 | “柯達”顯影液與定影液 (未滅菌) | “KODAK”GBX DEVELOPER and FIXER (Non-Sterile) | P.1840 |
|
33
| 衛署醫器製壹第002186號 | 2008/6/26 | “新廣業”熱及濕氣凝結器(人工鼻)(未滅菌) | “HSINER”Heat and moisture condenser (artificial nose) (Non-Sterile) | D.5375 |
|
34
| 衛署醫器輸壹第006832號 | 2008/6/25 | "眼力健" 人工水晶體植入導引器(滅菌) | "AMO" Unfolder Implantation Handpieces And Cartridges(sterile) | M.4300 |
|
35
| 衛署醫器製壹第002185號 | 2008/6/25 | “兆鋒”骨水泥分配器(滅菌) | “Mega Stone” Cement Dispenser(Sterile) | N.4200 |
|
36
| 衛署醫器輸壹第006837號 | 2008/6/25 | "捷健"好貼繃帶(未滅菌) | "HERBA" Hotek BANDAGE (Non-Sterile) | J.5240 |
|
37
| 衛署醫器輸第019393號 | 2008/6/25 | 貝克曼庫爾特協康天使塵檢驗試劑 | BECKMAN COULTER SYNCHRON Phencyclidine (PCP) Reagent | A.0001 |
|
38
| 衛署醫器輸壹第006831號 | 2008/6/25 | “喜伯樂” 硬式喉頭鏡組 (未滅菌) | “HILBRO”RIGID LARYNGOSCOPES (Non-Sterile) | D.5540 |
|
39
| 衛署醫器輸壹第006833號 | 2008/6/25 | “尼歐普”新珈碼射線偵測系統(未滅菌) | “Neoprobe”Gamma Detection System (Non-sterile) | P.1320 |
|
40
| 衛署醫器輸壹第006834號 | 2008/6/25 | "拓比" 瞳孔圖儀(未滅菌) | "Tobii" Pupillograph(Non-Sterile) | M.1690 |
|
41
| 衛署醫器輸壹第006835號 | 2008/6/25 | “捷健”安得繃帶 (未滅菌) | “HERBA” ANDE BANDAGE (non-sterile) | J.5240 |
|
42
| 衛署醫器輸壹第006836號 | 2008/6/25 | “捷健”易貼繃帶 (未滅菌) | “HERBA” ETEK BANDAGE (non-sterile) | J.5240 |
|
43
| 衛署醫器輸壹第006826號 | 2008/6/24 | 佑康 揣業駒 專家型螢光分析儀 | PGI Triage MeterPro | A.2560 |
|
44
| 衛署醫器輸壹第006830號 | 2008/6/24 | "依免可"檢體稀釋液 | "Immucor"Specimen Diluent | B.8200 |
|
45
| 衛署醫器輸壹第006829號 | 2008/6/24 | "依免可"磷酸緩衝溶液 | "Immucor"pHix | B.4010 |
|
46
| 衛署醫器輸第018920號 | 2008/6/24 | “奧林柏斯”軟式膽道鏡及附件 | “OLYMPUS”Choledocho fiberscope And Accessories | H.1500 |
|
47
| 衛署醫器輸第018918號 | 2008/6/24 | “奧林柏斯”電子鼻咽腔鏡及附件 | “OLYMPUS”RHINO-LARYNGO VIDEOSCOPE AND ACCESSORIES | G.4760 |
|
48
| 衛署醫器輸壹第006827號 | 2008/6/24 | 佑康 揣業駒 加強型螢光份析儀 | PGI Triage MeterPlus | A.2560 |
|
49
| 衛署醫器輸壹第006828號 | 2008/6/24 | “邁世代”手動式眼科手術器械 (未滅菌) | “MST” Manual Ophthalmic Surgical Instrument (Non-Sterile) | M.4350 |
|
50
| 衛署醫器輸壹第006824號 | 2008/6/23 | “密陀來福”羊水暨囊胞取樣針組 (滅菌) | “Vitrolife”Needle for amniocentesis and cyst puncture (Sterile) | L.1550 |
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