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Medical endoscope cold light source - NMPA Registration 粤械注准20242061260

Access comprehensive regulatory information for Medical endoscope cold light source in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242061260 and owned by Edan Instruments, Inc.. The device was approved on September 26, 2024.

This page provides complete registration details including registrant information, province location (Guangdong), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.

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Class II
粤械注准20242061260
Medical endoscope cold light source
医用内窥镜冷光源
NMPA Registration Number: 粤械注准20242061260
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Intended Use
English

It is used in medical institutions for endoscopic diagnosis and/or treatment/surgery to provide observation illumination for the field of view of endoscopic observation of human body cavities, and is used in conjunction with indocyanine that has been approved for marketing in China and has the same application site.

中文

在医疗机构中使用,用于内窥镜诊断和/或治疗/手术中,为内窥镜观察人体体腔的视场区域提供观察用照明,配合已在中国批准上市且应用部位一致的吲哚菁緑使用。

Device Classification
Device Class
Class II
Model Specifications
LT30、LT60、LT30R、LT60R
Approval Department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration Information
Registration Number
粤械注准20242061260
Approval Date
September 26, 2024
Expiry Date
September 25, 2029
Registrant
Name
Edan Instruments, Inc.
深圳市理邦精密仪器股份有限公司
Province/Region
Guangdong
广东
Address
No. 15, Jinhui Road, Jinsha Community, Kengzi Street, Pingshan New District, Shenzhen
深圳市坪山新区坑梓街道金沙社区金辉路15号
Production Facility
Production Address
深圳市坪山新区坑梓街道金沙社区金辉路15号
Structure and Composition
English

It consists of a light source host and a cable (excluding light guide).

中文

由光源主机和线缆(不含导光束)组成。

Additional Information
Appendix
产品技术要求