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※※應以登錄方式取得上市許可之醫療器材品項※※
| 發布日期:2021-04-29 | 更新日期:2023-10-25 發布單位:醫療器材及化粧品組

應以登錄方式取得上市許可之醫療器材品項

序號

代碼

中文名稱

英文名稱

等級

1

A.2150

臨床使用的連續流動式多項化學分析儀

Continuous flow sequential multiple chemistry analyzer for clinical use

1

2

A.2160

臨床使用的個別式光度量測化學分析儀

Discrete photometric chemistry analyzer for clinical use

1

3

A.2260

臨床使用的高壓液相層析儀

High pressure liquid chromatography system for clinical use

1

4

A.2300

臨床使用的色度計、光度計或分光光度計

Colorimeter, photometer, or spectrophotometer for clinical use

1

5

A.2485

臨床使用的電泳設備

Electrophoresis apparatus for clinical use

1

6

A.2500

臨床使用的酵素分析儀

Enzyme analyzer for clinical use

1

7

A.2560

臨床使用的螢光儀

Fluorometer for clinical use

1

8

A.2900

自動尿液分析系統

Automated urinalysis system

1

9

B.1850

染料及化學溶液染料

Dye and chemical solution stains

1

10

B.9195

血液混合器及血液重量分析裝置

Blood mixing devices and blood weighing devices

1

11

B.9275

體外診斷用血庫離心機

Blood bank centrifuge for in vitro diagnostic use

1

12

C.4540

免疫比濁計

Immunonephelometer equipment

1

13

D.2320

無補償式管流量計

Uncompensated thorpe tube flowmeter

1

14

D.2340

補償式管流量計

Compensated thorpe tube flowmeter

1

15

D.2610

氣體壓力計

Gas pressure gauge

1

16

D.2700

壓力調節器

Pressure regulator

1

17

F.3140

樹脂塗敷器

Resin applicator

1

18

F.3661

CAD/CAM光學取模系統

Optical Impression Systems for CAD/CAM

1

19

F.3670

樹脂印模牙托材

Resin impression tray material

1

20

F.6010

研磨裝置及其附件

Abrasive device and accessories

1

21

F.6050

唾液吸收器

Saliva absorber

1

22

F.6140

咬合紙

Articulation paper

1

23

F.6290

磨光劑載杯

Prophylaxis cup

1

24

F.6300

橡皮障及其附件

Rubber dam and accessories

1

25

F.6570

印模管

Impression tube

1

26

F.6880

成形印模牙托

Preformed impression tray

1

27

F.6890

口內牙科用臘

Intraoral dental wax

1

28

H.1400

胃的酸鹼度電極

Stomach pH electrode

1

29

H.5970

疝脫支撐器

Hernia support

1

30

I.3800

體外美容用修復彌補物

External aesthetic restoration prosthesis

1

31

I.3910

非膨脹式四肢用夾板

Noninflatable extremity splint

1

32

J.5100

交流電力可調整式病床

AC-powered adjustable hospital bed

1

33

J.5120

手動可調整式病床

Manual adjustable hospital bed

1

34

J.5140

小兒病床

Pediatric hospital bed

1

35

J.5150

非動力式浮動治療床墊

Nonpowered flotation therapy mattress

1

36

J.5160

醫療用束帶

Therapeutic medical binder

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

M.1140

眼科用椅

Ophthalmic chair

1

41

M.1350

角膜鏡

Keratoscope

1

42

M.1460

立體感測量器

Stereopsis measuring instrument

1

43

M.1605

視野鏡

Perimeter

1

44

M.1700

瞳孔計

Pupillometer

1

45

M.1760

自動眼科驗光機

Ophthalmic refractometer

1

46

M.1770

手動式驗光儀

Manual refractor

1

47

M.1870

立體鏡

Stereoscope

1

48

M.4770

眼科用手術眼鏡(放大鏡)

Ophthalmic operating spectacles (loupes)

1

49

N.5850

非動力式骨科牽引器及配件

Nonpowered orthopedic traction apparatus and accessories

1

50

O.1575

測力板

Force-measuring platform

1

51

O.1925

等速肌力試驗評估系統

Isokinetic Testing and Evaluation System

1

52

O.3075

醫療用手杖

Cane

1

53

O.3150

醫療用柺杖

Crutch

1

54

O.3410

體外肢體裝具用組件

External limb orthotic component

1

55

O.3420

體外肢體義肢用組件

External limb prosthetic component

1

56

O.3475

肢體裝具

Limb orthosis

1

57

O.3490

軀幹裝具

Truncal orthosis

1

58

O.3520

治療檯

Plinth

1

59

O.3640

手臂吊帶/醫療用三角巾

Arm sling/triangle bandage

1

60

O.5125

非動力式坐浴

Nonpowered sitz bath

1

61

O.5700

醫療用冷熱敷裝置

Cold/Hot pack

1

62

O.5730

醫療用濕熱敷包

Moist heat pack

1

63

O.5740

動力式熱敷墊

Powered heating pad

1

64

O.5925

牽引用附件

Traction accessory

1

65

P.1320

核醫攝取探頭

Nuclear uptake probe

1

66

P.1700

診斷用X光機高壓產生器

Diagnostic x-ray high voltage generator

1

67

P.1920

放射線造影頭部固定器

Radiographic head holder

1

68

P.1980

放射線檯

Radiographic table

1