Korea Medical Device Safety Information Agency Item Code: 2020
Serial Number
Name
Last Modified Date
Item Code
1
Class 1 U-Healthcare Gateway
2018-12-05
A90010.01
2
Class 2 U-Healthcare Gateway
2018-12-05
A90010.02
3
Secondary Healing Saline Wound Dressing
2015-12-20
B07070.06
4
Secondary Healing Foam Wound Dressing
2015-12-20
B07070.12
5
Secondary Healing Hydrogel Wound Covering material
2015-12-20
B07070.04
6
4th generation dentin bonding system
2017-12-12
C12010.01
7
5th generation dentin bonding system
2017-12-12
C12020.01
8
6th generation dentin bonding system
2017-12-12
C12030.01
9
7th generation dentin bonding system
2017-12-12
C12040.01
10
HIV·HBV·HCV·HTLV immune test reagent
2015-12-19
D04140. 01
11
HIV·HBV·HCV·HTLV Genetic Test Reagent
2015-12-19
D06070.01
12
HIV·HBV·HCV·HTLV Genetic Test Reagent
2015-12-19
D06060.01
13
HIVHBVHCVHTLV Genetic Test Reagent
2017-12-12
D06060.01
14
Gas Anesthesia Machine
2017-12-12
A06010.01
15
Gas Anesthesia Machine
2013-12-18
A06010
16
Gas Type Pharmaceutical infusion pump
2015-12-20
A79010.05
17
Gas-type pharmaceutical infusion pump
2017-01-07
A79010.06
18
Heated inhaler
2017-12-12
A81010.01
19
Heated sealing wound Covering material
2015-12-20
B07070.15
20
Keratoscope
2013-01-18
A28020.01
21
Keratometry instrument
2013-01-18
A28060.01
22
Keratometry instrument
2016-12-24
A20860.01
23
Corneal endothelial photographing device
2013-01-18
A2808 0.01
24
Interferential current type low frequency stimulator
2013-12-18
A16010.02
25
Interferential current type low frequency stimulator
2017-12-11
A16010.02
26
Simple color vision tester
2013-01-18
A28220.01
27
Indirect X-ray device
2016-12-19
A11070.01
28
Gamma counter
2015-12-28
A13140.01
29
Gamma camera
2015-12-28
A13110.01
30
Gamma ray bone density Measuring Instruments
2015-12-28
A13160.01
31
Personal Air Heater
2013-01-17
A83060.02
32
Personal Light Irradiator
2018-12-05
A83050.01
33
Personal Material Heater
2013-01-17
A83060.03
34
Personal Heater
2013-01-17
A83060.01
35
Personal Artificial Respirator
2016-12-19
A07010.0 2
36
Personal low frequency stimulator
2017-12-11
A83010.01
37
Personal low frequency stimulator
2013-12-18
A83010.01
38
Personal infrared irradiator
2013-01-18
A83030.01
39
Personal electric stimulator
2013-01-22
A83000
40
Personal combination stimulator
2013-12-18
A83080.01
41
Personal combination stimulator (if it has the corresponding function) )
2017-12-11
A83080.01
42
Personal continuous blood glucose monitoring system
2018-12-05
A22030.03
43
Personal external blood glucose monitoring system
2020-01-25
A22030.02
44
Personal ultrashortwave stimulator
2013-12-18
A83070.01
45
Personal Ultrasound Stimulator
2013-12-18
A83100
46
Personal Ultrasound Stimulator
2013-12-18
A83100.01
47
Reagents for Personal Blood Glucose Meter
2013-12-17
D10030.02
48
Personal Blood Glucose Metering System
2014-12-26
A22030.02
49
Standard Extracorporeal Ultrasound Probe
2015-12-27
A58020.07
50
Standing digital circulatory system X-ray fluoroscopy diagnostic device
2017-12-12
A11090.03
51
Standing digital circulatory system X-ray fluoroscopy diagnostic device
2013-01-18
A11090.03
52
Standing incubator
2013-12-18
A10010.01
53
Standing analog circulatory system X-ray fluoroscopy diagnostic device
2016-12-19
A11090.04
54
Dry heat Sterilizer
2015-12-19
A04040.01
55
Ophthalmoscope
2013-01-18
A28120.01
56
Ophthalmoscope Lens Set
2013-01-18
A28190.01
57
Ophthalmoscope Lens Frame
2013-01-18
A28200.01
58
Ophthalmoscope Device
2014-12-22
A28000
59
Ophthalmic Photo-Stimulator
2013-01-18
A28150.01
60
Ophthalmic Refractive Power Meter
2013-01-18
A28030.01
61
Ophthalmic Lens
2013-01-18
A28170.01
62
Ophthalmic Plate Attachment Lens
2013-01-18
A28180.01
63
Ophthalmic Prism
20 13-01-18
A28175.01
64
검영기
2013-01-18
A28070.01
65
경성시형색소경
2018-12-05
A31250.01
66
경성팽반경
2018-12-05
A31260.01
67
경성팽반경
2018-12-05
A31260.04
68
경성아르경
2018-12-05
A 31140.01
69
Kyungsung Oral Speculum
2018-12-05
A31090.02
70
Kyungsung Bronchoscope
2018-12-05
A31110.01
71
Kyungsung Ovarian Speculum
2018-12-05
A31280.04
72
Kyungsung Nudo Speculum
2018-12-05
A31090.39
73
Kyungsung Bladder Speculum
2018-12-05
A31180.01
74
Rigid Cystourethroscope
2018-12-05
A31200.01
75
Rigid Laparoscope
2018-12-05
A31290.01
76
Rigid Sinusoscope
2018-12-05
A31090.05
77
Rigid Rhinoscope
2018-12-05
A31310.04
78
Rigid Rhinopharyngoscope
2018-12-05
A31310.07
79
Rigid Insertion Tube Yong-Long-Dong-Gyeong
2018-12-05
A31100.08
80
Kyung-Sung-Maxilla-Dong-Gyeong
2018-12-05
A31090.08
81
Kyung-Sung-Plastic-Surgery-Endoscopy
2018-12-05
A31090.10
82
Kyung-Sung-Esophagus-Gyeong
2018-12-05
A31120.01
83
Kyung-Sung-Neuronoscopy
2018-12-05
A31350.01
84
Kyung-Sung-Woo-Gyeong
2018-12-05
A31240.01
85
Gyeongseong Ureteroscope
2018-12-05
A31230.01
86
Gyeongseong Ureteroscope
2018-12-05
A31090.14
87
Gyeongseong Ureteroscope
2018-12-05
A31270.01
88
Gyeongseong Lumbaroscope
2018-12-05
A31090.17
89
Gyeongseong Gastroscope
2018-12-05
A31190.01
90
Kyungsung Yugwankyung
2018-12-05
A31090.20
91
Kyungsung Pharyngotyonkyung
2018-12-05
A31090.13
92
Kyungsung Jagyungkyung
2018-12-05
A31280.01
93
Kyungsung Mediastinkyung
2018-12-05
A31130.01
94
Kyungsung Rectokkyungkyung
2018-12-05
A31210.01
95
Gyeongseong Spinal Column
2018-12-05
A31090.23
96
Gyeongseong Spinal Column
2018-12-05
A31090.26
97
Gyeongseong Nasopharyngeal Column
2018-12-05
A31310.01
98
Gyeongseong Anorectal Column
2018-12-05
A31160.01
99
Gyeongseong Thoracoscopy
2018-12-05
A31090.29
100
Percutaneous Oxygen chamber
2015-12-27
A08020.01
101
Transcutaneous pain relief electrical stimulation device
2013-12-18
A16010.03
102
Transcutaneous pain relief electrical stimulation device
2017-12-11
A16010.03
103
Transcutaneous blood gas analyzer
2013-12-18
A17140.01
104
High intensity focused Ultrasonic surgical instrument
2015-12-27
A35100.02
105
Tympanic membrane perforation tube
2013-01-17
A57380.01
106
High-frequency artificial respiration
2016-12-19
A07010.03
107
High-speed centrifuge
2013-01-17
A32010.02
108
High-speed centrifuge
2017-12-11
A32010.02
109
High-risk infectious agent immune test reagent
2020-01-25
D04160.01
110
High-risk infectious agent genetic test reagent
2020-01-25
D06080.01
111
High-power light irradiator
2018-12-05
A16060.01
112
Bone-shaped hearing aid
2016-12-24
A78010.01
113
Bone graft composite material
