合針、血壓計、體溫計、心電圖機、腦電圖機、顯微鏡、針灸針、生化分析系統、助聽(tīng)器、超聲消毒設備、不可吸收縫合線(xiàn)等。

要求：

1.商用性質(zhì)辦公60平，倉儲40平

2.2名醫學(xué)專(zhuān)業(yè)人員為企業(yè)負責人

3.產(chǎn)品經(jīng)營(yíng)目錄

注：符合以上3點(diǎn)，基本上就可以辦理二類(lèi)醫療器械備案

提供材料

1.二類(lèi)醫療器械備案申請書(shū)

2.營(yíng)業(yè)執照或預先核名通知書(shū)

3.法定代表人、企業(yè)負責人、質(zhì)量負責人的身份證明、學(xué)歷或者職稱(chēng)證明復印件

4.經(jīng)營(yíng)場(chǎng)所、庫房地址的地理位置圖、平面圖、房屋產(chǎn)權證明文件或者租賃協(xié)議(附房屋產(chǎn)權證明文件)復印件 5.產(chǎn)品經(jīng)營(yíng)目錄表

6.產(chǎn)品合格證書(shū)

7.上家購銷(xiāo)合同、進(jìn)貨渠道

ter, electrocardiogram machine, EEG machine, microscope, acupuncture needle, biochemical analysis system, hearing aid, ultrasonic disinfection e, non-absorbable sutures, etc. ask: 1. Commercial nature of the office 60 square, storage 40 square 2.2 medical professionals are the leaders of the enterprise 3. Product management catalogue Note: If the line of the above 3 points, basically can handle the record of class II medical devices Provide materials 1. Application for filing of Class II medical devices 2. Business license or pre-check name notice 3. Copy of the identity certificate, education background or professional title certificate of the legal representative, the person in charge of th