29 - 04 - 2024

 一、美國公司登記Establishment Registration

已協助台灣及香港多家廠商完成美國FDA公司登記程序。 

二、產品列名  (Device Listing)

1. 麻醉科(Anesthesiology)  呼吸咬嘴(Breathing mouthpiece
 經鼻氧氣套管(Nasal oxygen cannula
 儲氣囊(Reservoir bag)
  Venturi面罩(Venturi mask) 
 氧氣面罩(Oxygen mask)
2. 物理醫學科學(Physical Medicine Devices  電動輪椅(Powered wheeled stretcher
 義肢及裝具用附件 (Prosthetic and orthotic accessory)
 醫療用手杖(Cane)
 醫療用柺杖(Crutch)
 肢體裝具(Limb orthosis)
 軀幹裝具 ( Truncal orthosis)
 腰椎裝具 (Lumbar orthosis)
3. 毒理科(Toxicology   呼吸酒精試驗系統(Breath-alcohol test system)
4. 牙科(DENTAL )  漂白牙齒的熱源(Heat source for bleaching teeth)
 口內攝影機(Intra oral camera )
5. 胃腸病科及泌尿科(GASTROENTEROLOGY-UROLOGY)  內視鏡及其附件(Endoscope and accessories)
 胃腸管及其附件(Gastrointestinal tube and accessories)
6. 一般醫院及個人使用裝置(GENERAL HOSPITAL AND PERSONAL USE DEVICES)  輻射式嬰兒保溫器(Infant radiant warmer)
 血管內輸液套(Intravascular administration set)
 病患檢查用手套(Patient examination glove)
 醫用可拋棄式剪刀(Medical disposable scissors)
 醫用輔助襪(Medical support stocking)
 醫用鞋墊(Medical insole)
7. 婦產科(OBSTETRICAL AND GYNECOLOGICAL)  腹腔鏡灌入器(Laparoscopic insufflator)
8. 眼科學(OPHTHALMIC)  手動式眼科手術器械(Manual ophthalmic surgical instrument)
9. 骨科(ORTHOPEDIC)  臨床用骨水泥攪拌器(Cement mixer for clinical use
10.一般及整形外科手術(General And Plastic Surgery Devices)  精密手術工具&電動手術工具(Micro tools & Power tools)
 鋸片(Saw blade)
11.一般醫院及個人使用裝置(General Hospital And Personal Use Devices)  保健鞋墊 ( Liqua care Insoles)
 吸引/灌流系统 (Pulse Lavage system)

 

三、FDA 510(k)上市申請

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

 

四、醫療器材安全性及功能性試驗設計,執行 

醫材類別

產品名稱

等級

1. 骨科(Orthopedics 生物可吸收性骨釘骨板(Bioresorbable Bone Plates and Bone Screws

II

2. 牙科Dental 排齦材料(Gingival Retraction Paste

未分類

3. 體外檢測試劑(IVD 人類白血球抗原(Human leukocyte antigen

未分類

4. 骨科(Orthopedics 骨填補材(Bone Void FillerBone Graft

II

5. 一般醫院使用裝置(General Hospital 皮下植入式血管內注射口及導管(Subcutaneous, implanted, intravascular infusion port and catheter)

II

6. 牙科Dental 人工牙根(Dental Implant

II

 

五、醫療器材臨床前試驗設計,執行 

醫材類別

產品名稱

等級

1. 骨科(Orthopedics 生物可吸收性骨釘骨板(Bioresorbable Bone Plates and Bone Screws

II

2. 牙科(Dental 排齦材料(Gingival Retraction Paste

未分類

3. 體外檢測試劑(IVD 人類白血球抗原(Human leukocyte antigen

未分類

4. 一般及整形外科(Plastics  膠原蛋白植入劑、玻尿酸皮下填補劑

III

5. 一般醫院使用裝置(General Hospital 皮下植入式血管內注射口及導管(Subcutaneous, implanted, intravascular infusion port and catheter)

II