免取得醫療器材製造許可品項草案
下表所列醫療器材品項未滅菌者，免取得製造許可。
序號 代碼 中文名稱 英文名稱 等級
1 A.2270 臨床使用的薄層色層分析系統 Thin-layer chromatography system for clinical use 1
2 B.1850 染料及化學溶液染料 Dye and chemical solution stains 1
3 C.2600 Wood氏螢光燈 Wood's fluorescent lamp 1
4 D.5220 吹氣瓶 Blow bottle 1
5 F.3140 樹脂塗敷器 Resin applicator 1
6 F.3220 頜與頜顳關節關係位置測量計 Facebow 1
7 F.3670 樹脂印模牙托材 Resin impression tray material 1
8 F.6010 研磨裝置及其附件 Abrasive device and accessories 1
9 F.6050 唾液吸收器 Saliva absorber 1
10 F.6140 咬合紙 Articulation paper 1
11 F.6200 基底塗料 Base plate shellac 1
12 F.6290 磨光劑載杯 Prophylaxis cup 1
13 F.6300 橡皮障及其附件 Rubber dam and accessories 1
14 F.6570 印模管 Impression tube 1
15 F.6870 拋棄式塗氟用牙托 Disposable fluoride tray 1
16 F.6880 成形印模牙托 Preformed impression tray 1
17 F.6890 口內牙科用臘 Intraoral dental wax 1
18 G.1500 味覺檢查計 Gustometer 1
19 G.3540 聽小骨置換物修正用器械 Prosthesis modification instrument for ossicular
replacement surgery 1
20 G.5220 耳鼻喉佈施藥裝置及其搭配使
用之物質
Ear, nose, and throat drug administration device and
contained substance 1
21 H.5210 手動式灌腸組套 Enema kit 1
22 H.5250 尿液收集器及其附件 Urine collector and accessories 1
23 H.5970 疝脫支撐器 Hernia support 1
24 I.3800 體外美容用修復彌補物 External aesthetic restoration prosthesis 1
25 I.3910 非膨脹式四肢用夾板 Noninflatable extremity splint 1
26 J.5075 彈性繃帶 Elastic bandage 1
27 J.5120 手動可調整式病床 Manual adjustable hospital bed 1
28 J.5150 非動力式治療床墊 Nonpowered flotation therapy mattress 1
29 J.5160 醫療用束帶 Therapeutic medical binder 1
30 J.5270 新生兒用眼罩 Neonatal eye pad 1
31 J.5300 醫療用吸收纖維 Medical absorbent fiber 1
32 J.5780 醫用輔助襪 Medical support stocking 1
33 J.5820 治療用陰囊支撐器 Therapeutic scrotal support 1
34 J.6025 吸收性尖端塗藥器 Absorbent tipped applicator 1
35 J.6230 壓舌板 Tongue depressor 1
36 J.6430 液體藥物給藥器 Liquid medication dispenser 1
37 J.6450 皮膚壓力保護器 Skin pressure protectors 1
38 J.6785 手動病患輸送裝置 Manual patient transfer device 1
39 J.6900 手提式擔架 Hand-carried stretcher 1
40 J.6960 灌洗注射筒 Irrigating syringe 1
41 J.6980 靜脈固定器 Vein stabilizer 1
42 K.1200 兩點式判讀儀 Two-point discriminator 1
43 K.1500 觸覺計 Esthesiometer 1
44 K.1525 調音叉 Tuning fork 1
序號 代碼 中文名稱 英文名稱 等級
45 M.1140 眼科用椅 Ophthalmic chair 1
46 M.1200 眼球運動鼓狀器 Optokinetic drum 1
47 M.1320 穹窿鏡 Fornixscope 1
48 M.1350 角膜鏡 Keratoscope 1
49 M.1375 Bagolini鏡片 Bagolini lens 1
50 M.1380 診斷用聚光鏡片 Diagnostic condensing lens 1
51 M.1390 診斷用彈性Fresnel鏡片 Flexible diagnostic Fresnel lens 1
52 M.1395 診斷用Hruby眼底鏡片 Diagnostic Hruby fundus lens 1
53 M.1400 瑪竇氏鏡 Maddox lens 1
54 M.1460 立體感測量器 Stereopsis measuring instrument 1
55 M.1605 視野鏡 Perimeter 1
56 M.1650 眼科用棒狀稜鏡 Ophthalmic bar prism 1
57 M.1655 眼科用Fresnel稜鏡(壓貼鏡片) Ophthalmic Fresnel prism 1
58 M.1665 眼科旋轉稜鏡 Ophthalmic rotary prism 1
59 M.1700 瞳孔計 Pupillometer 1
60 M.1770 手動式驗光儀 Manual refractor 1
61 M.1780 視網膜鏡 Retinoscope 1
62 M.1790 近點尺 Nearpoint ruler 1
63 M.1810 切線幕(視野計) Tangent screen (campimeter) 1
64 M.1870 立體鏡 Stereoscope 1
65 M.1905 眼球震顫帶 Nystagmus tape 1
66 M.1910 視覺分離試驗系統 Spectacle dissociation test system 1
67 M.4750 眼科用眼罩 Ophthalmic eye shield 1
68 M.4770 眼科用手術眼鏡(放大鏡) Ophthalmic operating spectacles (loupes) 1
69 M.5600 上眼瞼下垂支持器 Ptosis crutch 1
70 N.5850 非動力式骨科牽引器及配件 Nonpowered orthopedic traction apparatus and
accessories 1
71 N.5890 非侵入式牽引組件 Noninvasive traction component 1
72 N.5940 石膏類產品 Cast component 1
73 N.5980 手動式打石膏及拆石膏器械 Manual cast application and removal instrument 1 74 O.3025 義肢及裝具用附件 Prosthetic and orthotic accessory 1
75 O.3075 醫療用手杖 Cane 1
76 O.3150 醫療用柺杖 Crutch 1
77 O.3410 體外肢體裝具用組件 External limb orthotic component 1 78 O.3420 體外肢體義肢用組件 External limb prosthetic component 1
79 O.3475 肢體裝具 Limb orthosis 1
80 O.3490 軀幹裝具 Truncal orthosis 1
81 O.3520 治療檯 Plinth 1
82 O.3640 手臂吊帶 Arm sling 1
83 O.3665 先天性髖關節移位外展夾板 Congenital hip dislocation abduction splint 1
84 O.3675 丹尼布朗夾板 Denis Brown splint 1
85 O.3825 機械式助行器 Mechanical walker 1
86 O.5125 非動力式坐浴 Nonpowered sitz bath 1
87 O.5700 醫療用冷敷裝置 Cold pack 1
88 O.5730 醫療用濕熱敷包 Moist heat pack 1
89 O.5925 牽引用附件 Traction accessory 1
90 P.1920 放射線造影頭部固定器 Radiographic head holder 1
