Department

Update

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CMDE

Innovative Product Announcement:

1. Product Name: Urinary Tract Filler

Applicant: Chengdu Qiupu Biotechnology Co., Ltd.

2. Product Name: Additive Manufacturing Polyetheretherketone Patient-Matched Thoracic Rib Prosthesis

Applicant: Dimension (Xi'an) Biomedical Technology Co., Ltd.

3. Product Name: Drug-Eluting Peripheral Artery Stent System

Applicant: Shanghai Hongmai Medical Technology Co., Ltd.

4. Product Name: Shoulder Joint Replacement Surgery Navigation and Positioning System

Applicant: Beijing Eiston Medical Technology Co., Ltd.

5. Product Name: Non-Small Cell Lung Cancer Drug Sensitivity Test Kit (In Vitro Cell Culture Method)

Applicant: Beijing Siqi Medical Laboratory Co., Ltd.

6. Product Name: Upper Gastrointestinal Endoscopy Surgical Control System

Applicant: Shanghai Aohua Endoscopy Co., Ltd.

7. Product Name: 3D Printed Breast Reconstruction Tissue Engineering Scaffold

Applicant: Shenzhen Boruijie Biotechnology Co., Ltd.

8. Product Name: Microsurgery Control System

Applicant: Antai Weijing Medical Technology (Shanghai) Co., Ltd.

9. Product Name: Chest CT Image-Assisted Diagnosis Software

Applicant: Shanghai Lianying Intelligent Technology Co., Ltd.

10. Product Name: Intracranial Deep Electrode

Applicant: Beijing Zhiran Medical Technology Co., Ltd.

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CMDE

Priority review

Medical linear accelerator

Kechuang Super Precision (Nanjing) Technology Co., Ltd.

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CMDE

Priority review

Implantable neural stimulation sheet electrodes

Changzhou Ruishen'an Medical Devices Co., Ltd.

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CMDE

Registration Guideline

1. Intravascular ultrasound diagnostic equipment

2. Electrocoagulation cutting endoscope

3. Evaluation of the fluorescence imaging performance of active medical devices

4. Capsule endoscopy system

5. Urological laser treatment equipment

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Standardization Administration

Classification and Definition Interpretation of Dyeing Solution Products

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