医疗器械认证范围

Products

产品

*MD 0100 - General non-active, non-implantable medical devices

0100-普通无源非植入式医疗器械

   - *MD 0101 - Non-active devices for anaesthesia, emergency and intensive care

0101-无源麻醉，急救以及重症监护器械

   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis

0102-无源注射、输液、输血及透析器械。

   - *MD 0103 - Non-active orthopaedic and rehabilitation devices

0103-无源整形外科及康复器械。

   - *MD 0104 - Non-active medical devices with measuring function

0104-具备测量功能的无源医疗器械。

   - *MD 0105 - Non-active ophthalmologic devices

0105-无源眼科器械。

   - *MD 0106 - Non-active instruments

0106-无源装置。

   - *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing

0108-无源消毒、清洁、冲洗医疗器械

   - *MD 0109 - Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)

0109-无源试管受精及辅助生殖技术器械

*MD 0200 - Non-active implants

0200-无源植入物

   - *MD 0201 - Non-active cardiovascular implants

0201-无源心血管植入物。

   - *MD 0202 - Non-active orthopaedic implants

0202-无源整形外科植入物。

   - *MD 0203 - Non-active functional implants

0203-无源功能性植入物

   - *MD 0204 - Non-active soft tissue implants

0204-无源软组织植入物。

*MD 0300 - Devices for wound care

0300-伤口护理器械。

   - *MD 0301 - Bandages and wound dressings

0301-绷带及伤口敷料

   - *MD 0302 - Suture material and clamps

0302缝合材料及夹具。

   - *MD 0303 - Other medical devices for wound care

0303-其它伤口护理医疗器械

*MD 0400 - Non-active dental devices and accessories

0400-无源牙科器械及附件。

   - *MD 0401 - Non-active dental equipment and instruments

0401-无源牙科设备及装置。

   - *MD 0402 - Dental materials

0402牙科材料

   - *MD 0403 - Dental implants

0403-牙科植入物

*MD 1100 - General active medical devices

1100-普通有源医疗器械。

   - *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis

1101-体外循环、输液及透析器械

   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia

1102-呼吸系统用器械，包括氧疗用高压氧舱及吸入式麻醉器械

   - *MD 1103 - Devices for stimulation or inhibition

1103-刺激及抑制器械。

   - *MD 1104 - Active surgical devices

1104-有源外科器械。

   - *MD 1105 - Active ophthalmologic devices

1105-有源眼科器械。

   - *MD 1106 - Active dental devices

1106-有源牙科器械。

   - *MD 1107 - Active devices for disinfection and sterilization

1107-活性消毒及灭菌器械。

   - *MD 1108 - Active rehabilitation devices and active prostheses

1108-有源康复设备及有源假体

   - *MD 1109 - Active devices for patient positioning and transport

1109-患者安置及运送有源器械

   - *MD 1110 - Active devices for in vitro fertilisation (IVF) and assisted reproductive therapy (ART)

1110-试管受精及辅助生殖技术有源器械

   - *MD 1111 – Software

1111-软件

*MD 1200 - Devices for imaging

1200-成像设备

   - *MD 1201 - Imaging devices utilising ionizing radiation

1201-电离辐射成像设备

   - *MD 1202 - Imaging devices utilising non-ionizing radiation

1202-非电离辐射成像设备

*MD 1300 - Monitoring devices

1300-监视装置

   - *MD 1301 - Monitoring devices of non-vital physiological parameters

1301-非主要生理学参数监视装置

   - *MD 1302 - Monitoring devices of vital physiological parameters

1302-主要生理学参数监视装置。

*MD 1400 - Devices for radiation therapy and thermo therapy

1400-放射治疗及热疗器械。

   - *MD 1401 - Devices utilising ionizing radiation

1401-电离辐射器械

   - *MD 1402 - Devices utilising non-ionizing radiation

1402-非电离辐射器械

   - *MD 1403 - Devices for hyperthermia / hypothermia

1403-高烧/低烧器械

   - *MD 1404 - Devices for (extracorporal) shock-wave therapy (lithotripsy)

1404-体外震波碎石器械。