29 - 04 - 2024

醫材類別

產品名稱

等級

臨床化學及臨床毒理學

Clinical Chemistry and Clinical Toxicology

呼吸酒精試驗系統(Breath-alcohol test system

I

血液學

Hematology

血小板濃厚液收集套組(Platelet And Plasma Separator For Bone Graft Handling

II

紅白血球減白過濾器(Leukocyte reduction filter for red blood cells

II

麻醉學

Anesthesiology

手動緊急呼吸器(Manual emergency ventilator

II

霧化器(Breeze Nebulizer

II

心臟血管醫學

Cardiovascular

靜脈血栓防止機(DVT Compression Device, limb

II

心電圖機(ECG

II

穿戴式心電圖紀錄器(Wearable ECG recorder

II

牙科學

Dental

排齦材料*Gingival Retraction Paste

Unclassified

植牙用人工牙根(Dental Implant

II

牙科鈦膜固定系統(Bone plate, Intraosseous fixation screw

II

氧化鋯瓷塊(Porcelain powder for clinical use

II

牙根封填材料(Root canal filling material

II

低速牙科手機及其附件(Low speed dental handpiece and accessories

I

胃腸病科學及泌尿科學

Gastroenterology- Urology

腹腔手術取物袋(Specimen Retrieval System

II

S/I沖吸系列產品(Suction Irrigation

II

防霧塗料 Anti-Fog Solution

II

引流導管(Biliary drainage catheter and accessories

II

一般及整形外科手術

General and Plastic Surgery

腹腔、鏡手術器械(Laparoscopic Instrument

II

動力式抽吸幫浦 Powered Suction Pump

II

電燒刀 Electrosurgical Electrode

II

甲殼素敷料(Chito Gauze

Unclassified

LED手術燈系統(LED surgical lighting system

II

一般醫院使用裝置

General Hospital

皮下單腔針(Hypodermic single lumen needle

II

病患檢查用手套(Patient examination glove

I

針灸針(Acupuncture needle

II

親水性創傷覆蓋材(Hydrophilic wound dressing

Unclassified

醫療用衣物(Medical Apparel

II

神經科學

Neurological

經皮神經電刺激疼痛舒緩器(Transcutaneous electrical nerve stimulator for pain relief, TENS

II

脊椎手術導航系統(Orthopedic Stereotaxic Instrument

II

皮下電極針(Multi-paired subdermal needle electrodes

II

婦產科學

Obstetrical and Gynecological

子宮輸卵管攝影導管(Uterine manipulator/injector cannula

Unclassified

陰道子宮托(Vaginal pessary

II

子宮內膜吸引式刮除器及其附件(Endometrial suction curette and accessories

II

子宮輸卵管攝影導管(Uterine manipulator/injector cannula

Unclassified

氣腹針(Veress Needle

II

眼科學

Ophthalmic

軟式隱形眼鏡(Soft hydrophilic contact lens

II

骨科學

Orthopedic

生物可吸收性骨釘骨板*Bioresorbable Bone Plates and Bone Screws

II

椎弓螺釘系統(Pedicle screw spinal system

II

骨替代物(Bone graft substitute

II

物理醫學科學

Physical Medicine

肌肉刺激舒緩控制器(Powered muscle stimulator, EMS

II

遠紅外線治療儀(Far-infrared therapy unit

II

雷射增髮帽(Laser hair growth cap

II

放射學科學

Radiology

患者定位機器人(Patient positioning system

II

LCD醫用顯示器(LCD monitor

II

體外檢測試劑

IVD

人類白血球抗原#Human leukocyte antigen

Unclassified

血糖機(Blood Glucose Monitoring System

II

 

 

* 2000~2006 年於維綱生物科技公司參予並完成之申請案。

 

 

# 2006~2008年於麥德凱生科公司輔導國內廠商完成之申請案。