Source: Medical Device Innovation Network & Centre for Medical Device Evaluation (CMDE)
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On 10th January, 2018, Center for Medical Device Evaluation (CMDE) released the announcement Examination Results of Special Approval Application of Innovative Medical Device (No. 1, 2018), which intends to approve the 4 products from 4 enterprises by the special approval process. Details are below:
1. Product Name: Medical linear accelerator system
Applicant: Shanghai Liangying Medical Technology Co., Ltd.
2. Product Name: Transcatheter heart valves and accessories
Applicant: Edwards Lifesciences LLC
3. product name: Anastomotic reinforcement patch
Applicant: Beijing Bohui Reynolds Biotechnology Co., Ltd.
4. Product Name: Full Digital Positron Emission and X-ray Tomography Scanning System
Applicant: Hubei Ruishi Digital Medical Imaging Technology Co., Ltd.
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