Taiwan FDA registration 6084cfbd0da9a4be736254457e2c8ac9
“BestShape” Hemodialysis Information System
TW: “醫倍思”血液透析資訊整合系統
Registration details
- Analysis ID
- 6084cfbd0da9a4be736254457e2c8ac9
- License Form
- Ministry of Health Medical Device Manufacturing No. 006191
Company information
- Manufacturer
- Xinghe Biomedical Co., Ltd. Taichung Factory
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- WISTRON MEDICAL TECHNOLOGY CORPORATION
Product details
- Intended Use
- This product is a set of computer-aided software, used to assist medical personnel to view dialysis information, hemodialysis records, blood test reports through this product, this product can provide relevant information for medical personnel as a reference for interpretation.
- Product Type (Level 1)
- H Gastroenterology-urology devices
- Product Type (Level 2)
- H5820 Hemodialysis systems and accessories
- Import Information
- Produced in Taiwan, China; Contract manufacturing
Dates and status
- Registration Date
- Oct 26, 2018
- Expiry Date
- Oct 26, 2023
About this record
Access comprehensive regulatory information for “BestShape” Hemodialysis Information System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 6084cfbd0da9a4be736254457e2c8ac9 and manufactured by Xinghe Biomedical Co., Ltd. Taichung Factory. The authorized representative in Taiwan is WISTRON MEDICAL TECHNOLOGY CORPORATION.
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