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)

Unclassified

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

Unclassified

4. 毒理科(Toxicology ) 呼吸酒精試驗系統(Breath-alcohol test system)

I

5. 牙科(Dental 植牙用人工牙根(Dental Implant

II

6. 一般醫院及個人使用裝置(General Hospital 皮下單腔針 (Hypodermic single lumen needle)

II

7. 麻醉科(Anesthesiology 手動緊急呼吸器(Manual emergency ventilator)

II

8. 體外檢測試劑(IVD 血糖機(Blood Glucose Monitoring System)

II

9. 婦產科Obstetrics/Gynecology 子宮輸卵管攝影導管(uterine manipulator/injector cannula)

Unclassified

10. 婦產科Obstetrics/Gynecology 陰道子宮托(Vaginal pessary)

II

11. 婦產科Obstetrics/Gynecology 子宮內膜吸引式刮除器及其附件(Endometrial suction curette and accessories)

II

12. 婦產科Obstetrics/Gynecology 子宮輸卵管攝影導管(uterine manipulator/injector cannula)

Unclassified

13. 一般醫院及個人使用裝置(General Hospital 病患檢查用手套(Patient examination glove)

I

14. 眼科學Ophthalmic 軟式隱形眼鏡(Soft (hydrophilic) contact lens)

II

15. 一般醫院及個人使用裝置(General Hospital 針灸針(Acupuncture needle)

II

16. 一般醫院及個人使用裝置(General Hospital 親水性創傷覆蓋材(Hydrophilic wound dressing)

Unclassified

17. 一般醫院及個人使用裝置(General Hospital 醫療用衣物(Medical Apparel)

II

18.一般及整形外科手術(General & Plastic Surgery) 腹腔、鏡手術器械 (Laparoscopic Instrument)

II

19.胃腸病科學及泌尿科學(General & Plastic Surgery) 腹腔手術取物袋(Specimen Retrieval System)

II

20. 胃腸病科學及泌尿科學(General & Plastic Surgery S/I沖吸系列產品(Suction Irrigation)             II
21.婦產科學(Obstetrics/Gynecology) 氣腹針(Veress Needle)            II
22. 胃腸病科學及泌尿科學(General & Plastic Surgery) 防霧塗料 (Anti-Fog Solution)

II

23. 一般及整形外科手術(General & Plastic Surgery) 動力式抽吸幫浦 (Powered Suction Pump)

II

24. 一般及整形外科手術(General & Plastic Surgery) 電燒刀 (Electrosurgical Electrode)

II



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