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Disposable minimally invasive fascial suture device - NMPA Registration 京械注准20252020504

Access comprehensive regulatory information for Disposable minimally invasive fascial suture device in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20252020504 and owned by B.J.Zh.F.Panther Medical Equipment Co., Ltd.. The device was approved on January 16, 2025.

This page provides complete registration details including registrant information, province location (Beijing), 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
京械注准20252020504
Disposable minimally invasive fascial suture device
一次性使用微创筋膜缝合器
NMPA Registration Number: 京械注准20252020504
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Pricing
Intended Use
English

适用于腹腔镜手术中收拢组织、经皮缝合、以便闭合手术切口。

Device Classification
Device Class
Class II
Model Specifications
PFSB5.5 PFSB8.5 PFSB10.5 PFSB12.5 PFSB15.5
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20252020504
Approval Date
January 16, 2025
Expiry Date
January 15, 2030
Registrant
Name
B.J.Zh.F.Panther Medical Equipment Co., Ltd.
北京派尔特医疗科技股份有限公司
Province/Region
Beijing
北京
Address
No. 8, Shangcheng Road, Beiqijia Town, Changping District, Beijing
北京市昌平区北七家镇上承路8号
Production Facility
Production Address
北京市昌平区北七家镇上承路8号A区、B区、C区;
Storage Conditions and Expiration
English

5 years

中文

5年

Additional Information
Appendix
产品技术要求