第 027 卷 第 054 期

行政院公報20210325

衛生勞動篇

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

12345678910111213
1415161718

A.2270B.1850C.2600D.5220F.3140F.3220F.3670F.6010F.6050F.6140F.6200F.6290F.6300F.6570F.6870F.6880F.6890G.1500

臨床使用的薄層色層分析系統
染料及化學溶液染料
Wood氏螢光燈
吹氣瓶
樹脂塗敷器
頜與頜顳關節關係位置測量計
樹脂印模牙托材
研磨裝置及其附件
唾液吸收器
咬合紙
基底塗料
磨光劑載杯
橡皮障及其附件
印模管拋棄式塗氟用牙托
成形印模牙托
口內牙科用臘
味覺檢查計11111111111111111119

G.3540 聽小骨置換物修正用器械

20G.522021222324252627282930313233
34353637383940414243
44

H.5210H.5250H.5970I.3800I.3910J.5075J.5120J.5150J.5160J.5270J.5300J.5780J.5820J.6025
J.6230J.6430J.6450J.6785J.6900J.6960J.6980K.1200K.1500K.1525Thin-layer chromatography system for clinical use
Dye and chemical solution stains
Wood's fluorescent lamp
Blow bottle
Resin applicator
Facebow
Resin impression tray material
Abrasive device and accessories
Saliva absorber
Articulation paper
Base plate shellac
Prophylaxis cup
Rubber dam and accessories
Impression tube
Disposable fluoride tray
Preformed impression tray
Intraoral dental wax
Gustometer
Prosthesis modification instrument for ossicularreplacement surgery
Ear, nose, and throat drug administration device andcontained substance
Enema kit
Urine collector and accessories
Hernia support
External aesthetic restoration prosthesis
Noninflatable extremity splint
Elastic bandage
Manual adjustable hospital bed
Nonpowered flotation therapy mattress
Therapeutic medical binder
Neonatal eye pad
Medical absorbent fiber
Medical support stocking
Therapeutic scrotal support
Absorbent tipped applicator
Tongue depressor
Liquid medication dispenser
Skin pressure protectors
Manual patient transfer device
Hand-carried stretcher
Irrigating syringe
Vein stabilizer
Two-point discriminator
Esthesiometer
Tuning fork

耳鼻喉佈施藥裝置及其搭配使
用之物質
手動式灌腸組套尿液收集器及其附件疝脫支撐器體外美容用修復彌補物
非膨脹式四肢用夾板彈性繃帶
手動可調整式病床
非動力式治療床墊
醫療用束帶新生兒用眼罩醫療用吸收纖維
醫用輔助襪
治療用陰囊支撐器
吸收性尖端塗藥器壓舌板液體藥物給藥器
皮膚壓力保護器
手動病患輸送裝置
手提式擔架
灌洗注射筒
靜脈固定器
兩點式判讀儀觸覺計
調音叉111111111111111111111111
1
1

第 027 卷 第 054 期

行政院公報

序號

代碼

中文名稱

45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69

M.1140M.1200M.1320M.1350M.1375
M.1380M.1390M.1395
M.1400M.1460M.1605
M.1650M.1655
M.1665
M.1700M.1770M.1780M.1790M.1810M.1870M.1905
M.1910M.4750M.4770M.5600

眼科用椅
眼球運動鼓狀器
穹窿鏡
角膜鏡
Bagolini鏡片診斷用聚光鏡片診斷用彈性Fresnel鏡片診斷用Hruby眼底鏡片瑪竇氏鏡立體感測量器視野鏡
眼科用棒狀稜鏡
眼科用Fresnel稜鏡(壓貼鏡片)眼科旋轉稜鏡瞳孔計
手動式驗光儀視網膜鏡
近點尺切線幕(視野計)
立體鏡
眼球震顫帶
視覺分離試驗系統
眼科用眼罩
眼科用手術眼鏡(放大鏡)
上眼瞼下垂支持器

70

N.5850非動力式骨科牽引器及配件

71
72
73
74
75
76
77
78
7980
81
82
83
84
85
86
87
88
89
90

N.5890N.5940N.5980O.3025
O.3075
O.3150O.3410O.3420O.3475
O.3490O.3520O.3640O.3665
O.3675
O.3825O.5125
O.5700O.5730O.5925
P.1920非侵入式牽引組件
石膏類產品
手動式打石膏及拆石膏器械
義肢及裝具用附件
醫療用手杖醫療用柺杖體外肢體裝具用組件
體外肢體義肢用組件
肢體裝具軀幹裝具治療檯
手臂吊帶
先天性髖關節移位外展夾板
丹尼布朗夾板
機械式助行器
非動力式坐浴醫療用冷敷裝置
醫療用濕熱敷包
牽引用附件
放射線造影頭部固定器

20210325英文名稱
Ophthalmic chair
Optokinetic drum
Fornixscope
Keratoscope
Bagolini lensDiagnostic condensing lensFlexible diagnostic Fresnel lensDiagnostic Hruby fundus lens
Maddox lensStereopsis measuring instrument
Perimeter
Ophthalmic bar prism
Ophthalmic Fresnel prism
Ophthalmic rotary prism
Pupillometer
Manual refractor
Retinoscope
Nearpoint ruler
Tangent screen (campimeter)
Stereoscope
Nystagmus tape
Spectacle dissociation test system
Ophthalmic eye shield
Ophthalmic operating spectacles (loupes)
Ptosis crutch
Nonpowered orthopedic traction apparatus andaccessories
Noninvasive traction component
Cast component
Manual cast application and removal instrument
Prosthetic and orthotic accessory
CaneCrutch
External limb orthotic component
External limb prosthetic component
Limb orthosis
Truncal orthosis
PlinthArm sling
Congenital hip dislocation abduction splint
Denis Brown splint
Mechanical walker
Nonpowered sitz bath
Cold pack
Moist heat pack
Traction accessory
Radiographic head holder

衛生勞動篇

等級
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