25/9/2018
Healgoo Interactive's fundus image processing software (Fundus Image Intelligent Analysis System) obtained China Medical Device Registration Certificate (Class 2)
The fundus image processing software (Fundus Image Intelligent Analysis System) independently developed by Healgoo Interactive was awarded the Medical Device Registration Certificate (Class 2) issued by Guangdong Food and Drug Administration, China on September 25, 2018.
The specific certification information is as follows:
| Guangdong Medical Device Registration Certificate (Class 2) | |
|---|---|
| Registration Number | YueXieZhuZhun-20182210852 |
| Company Name | Guangzhou Healgoo Interactive Medical Technology Co., Ltd. |
| Product Name | Fundus Image Processing Software |
| Model and specification | V1.0 |
| Structure and composition | The Fundus Image Intelligent Analysis System is mainly composed of a patient registration module, a patient information input module, an image uploading module, an image grading module, an automatic electronic report acquiring module, a report browsing module, and a statistical module. |
| Product Scope / Intended Use | It is suitable for collecting digital images of the retina without using a mydriatic agent, and performing fundus disease analysis through images. |
| Company Address | Room A312, No. 75, Xian Lie Zhong Road, Yuexiu District, Guangzhou |
| Date of Issue | 2018-9-25 |
| Effective Deadline | 2023-9-24 |
| Merchandise Name | |
| Date of Change | |
| Changed Content | |
| Registration Number Status | Normal |
| Remarks | The original "Medical Devices Classification Catalogue" product classification code: 6870. |