| Panel |
CFR Number |
Regulation Name/Device
Name |
Class |
| Anesthesiology |
| 1 |
868.5630 |
NEBULIZER
霧化治療器 |
II |
| Clinical |
| 2 |
862.1065 |
AMMONIA TEST SYSTEM
氨測試系統 |
I |
| |
|
BILIRUBIN (TOTAL AND UNBOUND) IN
THE NEONATE TEST SYSTEM
新生兒膽紅素(總量及未結合的)試驗系統 |
|
| 4 |
862.1150 |
CALIBRATOR
比對標準品 |
|
| 5 |
862.1155 |
HUMAN CHORIONIC GONADOTROPIN (HCG)
TEST SYSTEM
人類絨毛膜性腺激素試驗系統 |
|
| 6 |
862.1160 |
BICARBONATE/CARBON DIOXIDE TEST
SYSTEM
二氧化碳測試系統 |
|
| 7 |
862.1170 |
CHLORIDE TEST SYSTEM
氯化物試驗系統 |
|
| 8 |
862.1225 |
CREATININE TEST SYSTEM
肌氨酸酐試驗系統 |
|
| 9 |
862.1310 |
GALACTOSE TEST SYSTEM
半乳糖試驗系統 |
|
| 10 |
862.1340 |
URINARY GLUCOSE (NONQUANTITATIVE)
TEST SYSTEM
尿中血糖(非量化)測試系統 |
|
| 11 |
862.1345 |
GLUCOSE TEST SYSTEM
血糖測試系統 |
|
| 12 |
862.1410 |
IRON (NON-HEME) TEST SYSTEM
鐵(非原血紅素)測試系統 |
|
| 13 |
862.1415 |
IRON-BINDING CAPACITY TEST BINDING
鐵結合能力測試系統 |
|
| 14 |
862.1495 |
MAGNESIUM TEST SYSTEM
鎂測試系統 |
|
| 15 |
862.1580 |
PHOSPHORUS (INORGANIC) TEST SYSTEM
亞磷酸(無機)測試系統 |
|
| 16 |
862.1600 |
POTASSIUM TEST SYSTEM
鉀測試系統 |
|
| 17 |
862.1660 |
QUALITY CONTROL MATERIAL (ASSAYED
AND UNASSAY)
品管物質(分析與非分析) |
|
| 18 |
862.1665 |
SODIUM TEST SYSTEM
鈉測試系統 |
|
| 19 |
862.1680 |
TESTOSTERONE TEST SYSTEM
睪固酮試驗系統 |
|
| 20 |
862.1730 |
FREE TYROSINE TEST SYSTEM
游離酥氨基酸試驗系統 |
|
| 21 |
862.1770 |
UREA NITROGEN TEST SYSTEM
尿素測試系統 |
|
| 22 |
862.1775 |
URIC ACID TEST SYSTEM
尿酸測試系統 |
|
| Cardiovascular |
| 23 |
870.1120 |
BLOOD PRESSURE CUFF
壓脈帶式血壓計 |
|
| 24 |
870.1130 |
NONINVASIVE BLOOD PRESSURE MEASUREMENT
SYSTEM
非侵入式血壓量測系統 |
|
| 25 |
870.2300 |
CARDIAC MONITOR (INCLUDING CARDIOTACHOMETER
AND RATE ALARM)
心臟監視器(心音、心跳警告功能) |
|
| 26 |
870.2330 |
ECHOCARDIOGRAPH
超音波心臟照影計 |
|
| 27 |
870.2340 |
ELECTROCARDIOGRAPH
心電圖機 |
II |
| 28 |
870.2350 |
ELECTROCARDIOGRAPH LEAD SWITCHING
ADAPTOR
心電圖導程切換接頭 |
II |
| 29 |
870.2360 |
ELECTROCARDIOGRAPH ELECTRODE
心電圖機電極片 |
II |
| 30 |
870.2370 |
ELECTROCARDIOGRAPH SURFACE ELECTRODE
TESTER
心電圖用體表電極測試器 |
II |
| 31 |
870.2880 |
ULTRASONIC TRANSDUCER
超音波換能器 |
II |
| Dental |
| 32 |
872.1800 |
EXTRAORAL SOURCE X-RAY
SYSTEM
口腔外X光機 |
II |
| 33 |
872.1810 |
INTRAORAL SOURCE X-RAY SYSTEM
口腔內X光機 |
II |
| 34 |
872.3060 |
GOLD BASED ALLOYS AND PRECIOUS METAL
ALLOYS FOR CLINICAL USE
牙科使用黃金基底合金和貴重金屬合金 |
II |
| 35 |
872.3200 |
RESIN TOOTH BONDING AGENT
樹脂牙黏著劑 |
II |
| 36 |
872.3275 |
DENTAL CEMENT
牙科補泥 |
II |
| 37 |
872.3660 |
IMPRESSION MATERIAL
牙模材料 |
II |
| 38 |
872.3690 |
TOOTH SHADE RESIN MATERIAL
補牙材料 |
II |
| 39 |
872.3700 |
DENTAL MERCURY (U.S.P)
牙科用汞齊 |
I |
| 40 |
872.3710 |
BASE METAL ALLOY
基底金屬合金 |
II |
| 41 |
872.4200 |
DENTAL HANDPIECES AND ACCESSORIES
牙科手持工具及附件 |
|
| 42 |
872.6250 |
CHAIR WITH A UNIT
牙科用椅及附件 |
|
|
43 |
872.6640 |
DENTAL OPERATIVE UNIT
牙科手術器械及附件 |
|
|
44 |
872.6710 |
BOILING WATER STERILIZER
沸水消毒鍋 |
|
| Gastroenterology |
| 45 |
876.1075 |
GASTROENTEROLOGY-UROLOGY
BIOPSY INSTRUMENT
腸胃科-泌尿科切片器械 |
II |
| 46 |
876.1500 |
ENDOSCOPE AND ACCESSORIES
內視鏡及附件 |
II |
| 47 |
876.4300 |
ENDOSCOPIC ELECTROSURGICAL
UNIT AND ACCESSORIES
內視鏡用電刀及其附件 |
II |
| 48 |
876.4480 |
ELECTROHYDRAULIC
LITHOTRIPTOR
水震波碎石機 |
II |
| 49 |
876.4500 |
MECHANICAL LITHOTRIPTOR
機械碎石機 |
II |
| 50 |
876.4620 |
URETERAL STENT
輸尿管支架 |
II |
| 51 |
876.5010 |
BILIARY CATHETER
AND ACCESSORIES
膽導管及附件 |
II |
| 52 |
876.5130 |
UROLOGICAL CATHETER
AND ACCESSORIES
泌尿導管及附件 |
II |
| 53 |
876.5160 |
UROLOGICAL CLAMPS FOR MALES
男性尿道夾 |
I |
|
54 |
876.5320 |
NONIMPLANTED ELECTRICAL
CONTINENCE DEVICE
非植入式電子排尿自制器材 |
II |
|
55 |
876.5665 |
WATER PURIFICATION
SYSTEM FOR DIALYSIS
血液透析用的水淨化系統 |
II |
| General Hospital |
| 56 |
880.2910 |
CLINICAL ELECTRONIC THERMOMETER
電子式體溫計 |
II |
| 57 |
880.5090 |
LIQUID BANDAGE
液體性繃帶 |
I |
| 58 |
880.5200 |
INTRAVASCULAR CATHETER
血管內導管 |
II |
| 59 |
880.5400 |
NEONATAL INCUBATOR
新生兒保溫箱 |
II |
| 60 |
880.5410 |
NEONATAL TRANSPORT INCUBATOR
可攜式新生兒保溫箱 |
II |
| 61 |
880.5440 |
INTRAVASCULAR ADMINISTRATION
SET
血管內輸液套 |
II |
| 62 |
880.5570 |
HYPODERMIC SINGLE
LUMEN NEEDLE
皮下注射單管腔針頭 |
II |
| 63 |
880.5680 |
PEDIATRIC POSITION
HOLDER
小兒姿勢固定器 |
I |
| 64 |
880.5725 |
INFUSION PUMP
輸液幫浦 |
II |
| 65 |
880.5860 |
PISTON SYRINGE
注射針筒 |
II |
| 66 |
880.6250 |
PATIENT EXAMINATION
GLOVE
醫檢手套 |
I |
| 67 |
880.6375 |
PATIENT LUBRICANT
病患用潤滑劑 |
I |
|
68 |
880.6760 |
PROTECTIVE RESTRAINT
保護性限制束帶 |
I |
| 69 |
880.6880 |
STEAM STERILIZER
蒸氣消毒鍋 |
II |
| 70 |
880.6885 |
LIQUID CHEMICAL STERILANTS/HIGH
LEVEL DISINFECTANTS
化學液體滅菌劑 |
II |
| Microbiology |
| 71 |
866.1620 |
ANTIMICROBIAL SUSCEPTIBILITY TEST
DISC
抗菌感受性試驗盤 |
II |
| 72 |
866.1640 |
ANTIMICROBIAL SUSCEPTIBILITY TEST
POWDER
抗菌感受性試驗粉末 |
II |
| 73 |
866.2390 |
TRANSPORT CULTURE MEDIUM
輸送培養基 |
I |
| 74 |
866.2560 |
MICROBIAL GROWTH MONITOR
微生物生長監視器 |
I |
| 75 |
866.2850 |
AUTOMATED ZONE READER
自動區域判讀器 |
I |
| 76 |
866.2900 |
MICROBIOLOGICAL SPECIMEN COLLECTION
AND TRANSPORT DEVICE
微生物樣本收集及輸送器材 |
I |
| 77 |
866.3110 |
CAMPYLOBACTER FETUS SEROLOGICAL
REAGENTS
胎兒彎曲畸形菌屬血清試劑 |
I |
| 78 |
866.3120 |
CHLAMYDIA SEROLOGICAL REAGENTS
披衣菌血清試劑 |
I |
| |
866.3235 |
EPSTEIN-BARR VIRUS SEROLOGICAL
REAGENTS
EB病毒血清試劑 |
I |
| |
866.3370 |
MYCOBACTERIUM TUBERCULOSIS IMMUNOFLUORESCENT
REAGENTS
結核桿菌免疫螢光試劑 |
I |
|
81 |
866.3870 |
TRYPANOSOMA SPP. SEROLOGICAL REAGENTS
錐虫血清試劑 |
I |
| Neurology |
| |
|
ATAXIAGRAPH
運動機能失調描記器 |
|
| |
|
ECHOENCEPHALOGRAPH
超音波腦波儀 |
|
| |
|
CORTICAL ELECTRODE
皮質電極 |
|
| |
|
ELECTROENCEPHALOGRAPH
腦電位計 |
|
| |
|
ELECTROENCEPHALOGRAM (EEG) SIGNAL
SPECTRUM ANALYZER
腦電位計頻譜分析儀 |
|
| |
|
NEUROLOGICAL ENDOSCOPE
神經科用內視鏡 |
|
| 88 |
|
VENTRICULAR CANNULA
腦室套管 |
|
| 89 |
|
SHUNT SYSTEM IMPLANTATION INSTRUMENT
分流系統植入用器械 |
|
| 90 |
|
TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR FOR PAIN RELIEF
減輕疼痛用經皮神經電刺激器 |
|
| Obstetrics/Gynecology |
| 91 |
884.1690 |
HYSTEROSCOPE AND ACCESSORIES
子宮鏡及附件 |
II |
| 92 |
884.1700 |
HYSTEROSCOPIC INSUFFLATOR
子宮鏡灌入器 |
II |
| 93 |
884.1720 |
GYNECOLOGIC LAPAROSCOPE AND ACCESSORIES
婦科用腹腔鏡及附件 |
II |
| 94 |
884.1730 |
LAPAROSCOPIC INSUFFLATOR
腹腔鏡灌入器 |
II |
| 95 |
884.2225 |
OBSTETRIC-GYNECOLOGIC ULTRASONIC
IMAGER
婦產科用超音波掃瞄儀 |
II |
| 96 |
884.2660 |
FETAL ULTRASONIC MONITOR AND ACCESSORIES
胎兒超音波監視器及附件 |
II |
| 97 |
884.2960 |
OBSTETRIC ULTRASONIC TRANSDUCER
AND ACCESSORIES
產科用超音波換能器及附件 |
II |
| 98 |
884.2980 |
TELETHERMOGRAPHIC SYSTEM
遠距溫度描記系統 |
I |
| 99 |
884.2982 |
LIQUID CRYSTAL THERMOGRAPHIC SYSTEM
液晶溫度描記系統 |
I |
| 100 |
884.4120 |
GYNECOLOGIC ELECTROCAUTERY AND
ACCESSORIES
婦產科電燒刀及其附件 |
II |
| 101 |
884.4550 |
GYNECOLOGIC SURGICAL LASER
婦科手術用雷射 |
II |
| 102 |
884.5300 |
CONDOM
衛生套 |
II |
| 103 |
884.5310 |
CONDOM WITH SPERMICIDAL LUBRICANT
附殺精劑之衛生套 |
II |
| 104 |
884.5460 |
SCENTED OR SCENTED DEODORIZED MENSTRUAL
TAMPON
具香味或除臭的衛生棉塞 |
II |
| 105 |
884.5470 |
UNSCENTED MENSTRUAL TAMPON
無香味的衛生棉塞 |
I |
| 106 |
884.6100 |
ASSISTED REPRODUCTION NEEDLE
輔助生殖之導引針 |
II |
| 107 |
884.6110 |
ASSISTED REPRODUCTION CATHETER
輔助生殖導管 |
II |
| 108 |
884.6120 |
ASSISTED REPRODUCTION ACCESSORY
輔助生殖附件 |
II |
| 109 |
884.6130 |
ASSISTED REPRODUCTION MICROTOOLS
輔助生殖之顯微器具 |
II |
| 110 |
884.6140 |
ASSISTED REPRODUCTION MICROTOOL
FABRICATION INSTRUMENTATION
輔助生殖之微吸管製造器械 |
II |
| 111 |
884.6150 |
ASSISTED REPRODUCTION MICROMANIPULATORS
AND MICROINJECTORS
輔助生殖顯微之控制及注射器材 |
II |
| 112 |
884.6160 |
ASSISTED REPRODUCTION LABWARE
輔助生殖用之實驗室器材 |
II |
| 113 |
884.6180 |
REPRODUCTIVE MEDIA AND SUPPLEMENTS
生殖用培養基及補充物 |
II |
| 114 |
884.6190 |
ASSISTED REPRODUCTION MICROSCOPE
AND MICROSCOPE ACCESSORIES
輔助生殖顯微鏡及其附件 |
I |
| Ophthalmic |
| 115 |
886.1570 |
OPHTHALMOSCOPE-2 CLASSES
眼底鏡 |
II |
| 116 |
886.1780 |
RETINOSCOPE
視網膜鏡 |
II |
| 117 |
886.1850 |
AC-POWERED SLIT-LAMP BIOMICROSCOPE
交流電力式細隙燈 |
II |
| 118 |
886.3400 |
KERATOPROSTHESIS
角膜彌補物 |
II |
| 119 |
886.4070 |
POWERED CORNEAL BURR
動力式角膜鑽孔器 |
I |
| 120 |
886.4150 |
VITREOUS ASPIRATION AND CUTTING
INSTRUMENT
玻璃體吸引及切割器械 |
II |
| 121 |
886.4300 |
INTRAOCULAR LENS GUIDE
人工水晶體導引器 |
I |
| 122 |
886.4370 |
KERATOME
角膜刀 |
I |
| 123 |
886.4390 |
OPHTHALMIC LASER
眼科雷射器材 |
II |
| 124 |
886.4392 |
ND: YAG LASER FOR POSTERIOR
CAPSULOTOMY
後囊切除用釹-雅各雷射 |
II |
| 125 |
886.4670 |
PHACOFRAGMENTATION SYSTEM
晶體乳化儀 |
II |
|
126 |
886.5916 |
RIGID GAS PERMEABLE CONTACT LENS
硬式透氣隱形眼鏡 |
II |
| 127 |
886.5918 |
RIGID GAS PERMEABLE CONTACT LENS
CAR PRODUCTS
硬式透氣隱形眼鏡保存用產品 |
II |
| 128 |
886.5925 |
SOFT (HYDROPHILIC) CONTACT LENS
軟式隱形眼鏡 |
II |
| 129 |
886.5928 |
SOFT (HYDROPHYLIC) CONTACT LENS
CARE PRODUCTS
軟式隱形眼鏡維護產品 |
II |
| Physical Medicine |
| 130 |
890.1385 |
DIAGNOSTIC ELECTROMYOGRAPH NEEDLE
ELECTRODE
診斷用肌電圖針電極 |
II |
| 131 |
890.3800 |
MOTORIZED THREE-WHEELED VEHICLE
醫療用電動三輪車 |
II |
| 132 |
890.3850 |
MECHANICAL WHEELCHAIR
手動輪椅 |
I |
| 133 |
890.3860 |
POWERED WHEELCHAIR
電動輪椅 |
II |
| 134 |
890.3880 |
SPECIAL GRADE WHEELCHAIR
特製輪椅 |
II |
| 135 |
890.3900 |
STANDUP WHEELCHAIR
站立式輪椅 |
II |
| 136 |
890.5100 |
IMMERSION HYDROBATH
浸泡式水浴 |
II |
|
137 |
890.5500 |
INFRARED LAMP
紅外線燈 |
II |
| 138 |
890.5710 |
HOT OR COLD DISPOSABLE PACK
拋棄式冷熱敷袋 |
I |
| 139 |
890.5850 |
POWERED MUSCLE STIMULATOR
動力式肌肉刺激器 |
II |
| Radiology |
| 140 |
892.1000 |
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
磁振診斷器材 |
II |
| 141 |
892.1100 |
SCINTILLATION GAMMA CAMERA
γ閃爍攝影機 |
I |
| 142 |
892.1110 |
POSITRON CAMERA
正子攝影機 |
I |
| 143 |
892.1200 |
EMISSION COMPUTED TOMOGRAPHY SYSTEM
放射電腦斷層掃描系統 |
II |
| 144 |
892.1310 |
NUCLEAR TOMOGRAPHIC SYSTEM
核醫斷層掃描系統 |
II |
| 145 |
892.1360 |
RADIONUCLIDE DOSE CALIBRATOR
放射核種劑量校準儀 |
II |
| 146 |
892.1540 |
NONFETAL ULTRASONIC MONITOR
非胎兒超音波監視器 |
II |
| 147 |
892.1550 |
ULTRASONIC PULSED DOPPLER IMAGING
SYSTEM
超音波都卜勒影像系統 |
II |
| 148 |
892.1560 |
ULTRASONIC PULSED ECHO IMAGING
SYSTEM DIAGNOSTIC
超音波影像系統 |
II |
| 149 |
892.1570 |
ULTRASONIC TRANSDUCER
診斷用超音波換能器 |
II |
| 150 |
892.1600 |
ANGIOGRAPHIC X-RAY SYSTEM
X光血管攝影系統 |
II |
| 151 |
892.1610 |
DIAGNOSTIC X-RAY BEAM LIMITING
DEVICE
診斷用X光遮光器 |
II |
| 152 |
892.1620 |
CINE OR SPOT FLUOROGRAPHIC X-RAY
CAMERA
連續或間斷式透視X光攝影機 |
II |
| 153 |
892.1630 |
ELECTROSTATIC X-RAY IMAGING SYSTEM
靜電式X光影像系統 |
II |
| 154 |
892.1650 |
IMAGE-INTENSIFIED FLUOROSCOPIC
X-RAY SYSTEM
透視型X光系統 |
II |
| 155 |
892.1670 |
SPOT FILM DEVICE
畫面分割攝影器材 |
II |
| 156 |
892.1680 |
STATIONARY X-RAY SYSTEM
固定式X光系統 |
II |
| 157 |
892.1710 |
MAMMOGRAPHIC X-RAY SYSTEM
乳房X光照射系統 |
II |
| 158 |
892.1720 |
MOBILE X-RAY SYSTEM
移動式X光系統 |
II |
159 |
892.1740 |
TOMOGRAPHIC X-RAY SYSTEM
X光斷層掃描系統 |
II |
| 160 |
892.1750 |
COMPUTED TOMOGRAPHY X-RAY SYSTEM
電腦斷層掃描系統 |
II |
| 161 |
892.1820 |
PNEUMOENCEPHALOGRAPHIC CHAIR
充氣腦X光攝影用椅 |
II |
| 162 |
890.1850 |
RADIOGRAPHIC FILM CASSETTE
放射線影片匣 |
II |
| 163 |
892.1870 |
RADIOGRAPHIC FILM/CASSETTE CHANGER
PROGRAMMER
放射線影片/換片匣之設定器 |
II |
| 164 |
892.1900 |
AUTOMATIC RADIOGRAPHIC-FILM PROCESSOR
自動式放射線影片處理器 |
II |
| 165 |
892.2030 |
MEDICAL IMAGE DIGITIZER
醫學影像數位器 |
II |
| 166 |
892.2040 |
MEDICAL IMAGE HARDCOPY DEVICE
醫學影像列印裝置 |
II |
| 167 |
892.2050 |
PICTURE ARCHIVING AND COMMUNICATIONS
SYSTEMS
醫學圖像紀錄傳輸系統 |
II |
| General & Plastic Surgery |
| 168 |
878.4400 |
ELECTROSURGICAL CUTTING AND COAGULATION
DEVICE AND ACCESSORIES
切割及止血用電刀及其附件 |
II |
| 169 |
878.4460 |
SURGEON'S GLOVES
手術手套 |
I |
| 170 |
878.4580 |
SURGICAL LAMP
手術燈 |
II |
| 171 |
878.4780 |
POWERED SUCTION PUMP
電動抽吸幫浦 |
II |
| 172 |
878.4810 |
LASER SURGICAL INSTRUMENT FOR USE
IN GENERAL & PLASTIC SURGERY & IN DERMATOLOGY
一般外科、整形外科及皮膚科用雷射儀 |
II |
| Toxicology |
| 173 |
862.3050 |
BREATH-ALCOHOL TEST SYSTEM
呼氣酒精測試系統 |
I |
| 174 |
862.3100 |
AMPHETAMINE TEST SYSTEM
安非他命試驗系統 |
II |
| 175 |
862.3110 |
ANTIMONY TEST SYSTEM
銻試驗系統 |
I |
| 176 |
862.3120 |
ARSENIC TEST SYSTEM
砷試驗系統 |
I |
| 177 |
862.3200 |
CLINICAL TOXICOLOGY CALIBRATOR
臨床毒物學校正器 |
II |
| 178 |
862.3220 |
CARBON MONOXIDE TEST SYSTEM
一氧化碳試驗系統 |
I |
| 179 |
862.3240 |
CHOLINESTERASE TEST SYSTEM
膽素酯酵素試驗系統 |
I |
| 180 |
862.3250 |
COCAINE AND COCAINE METABOLITE
TEST SYSTEM
可卡因及其代謝物試驗系統 |
II |
| 181 |
862.3270 |
CODEINE TEST SYSTEM
可待因試驗系統 |
II |
| 182 |
862.3280 |
CLINICAL TOXICOLOGY CONTROL MATERIAL
臨床毒物學控制工具 |
I |
| 183 |
862.3600 |
MERCURY TEST SYSTEM
汞試驗系統 |
I |
| 184 |
862.3610 |
METHAMPHETAMINE TEST SYSTEM
甲基安非他命試驗系統 |
II |
| 185 |
862.3620 |
METHADONE TEST SYSTEM
美沙酮試驗系統 |
II |
| 186 |
862.3640 |
MORPHINE TEST SYSTEM
嗎啡試驗系統 |
II |
| 187 |
862.3650 |
OPIATE TEST SYSTEM
鴉片試驗系統 |
II |
188 |
862.3750 |
QUININE TEST SYSTEM
奎寧試驗系統 |
I |
| 189 |
862.3850 |
SULFONAMIDE TEST SYSTEM
磺胺試驗系統 |
I |
190 |
862.3870 |
CANNABINOID TEST SYSTEM
大麻試驗系統 |
II |
191 |
Unclassified |
PHENCYCLIDINE (PCP) TEST SYSTEM:THIN LAYER CHROMATOGRAPHY
天使塵試驗系統:薄層層析法 |
|
192 |
Unclassified |
PHENCYCLIDINE (PCP) TEST SYSTEM:RADIOIMMUNOASSAY
天使塵試驗系統:輻射免疫分析法 |
|
|
193 |
Unclassified |
PHENCYCLIDINE (PCP) TEST SYSTEM:ENZYME IMMUNOASSAY
天使塵試驗系統:酵素免疫分析法 |
|
