Non-absorbent surgical sutures - NMPA Registration 京械注准20232020107

Access comprehensive regulatory information for Non-absorbent surgical sutures 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20232020107 and owned by B.J.Zh.F.Panther Medical Equipment Co., Ltd.. The device was approved on March 07, 2023.

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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NMPA Official Data

Class II

京械注准20232020107

Non-absorbent surgical sutures

非吸收性外科缝线

NMPA Registration Number: 京械注准20232020107

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Intended Use

English

For sutures of soft tissues, organs and/or skin.

中文

用于软组织、器官和/或皮肤的缝合。

Device Classification

Device Class

Class II

Model Specifications

Model specification Suture length (cm) color Needle type Needle curvature Chord length(mm) PE35TC001 0 90 Green, white Rounded corner needles 1/2 17 PE35TC002 0 120 Green, white Rounded corner needles 1/2 17 PE35TC003 0 75 Green, white Rounded corner needles 1/2 17 PE35TC004 0 90 Green, white Rounded corner needles 1/2 12

型号规格缝线长度(cm) 颜色针型针弧度弦长(mm) PE35TC001 0 90 绿色、白色圆体角针 1/2 17 PE35TC002 0 120 绿色、白色圆体角针 1/2 17 PE35TC003 0 75 绿色、白色圆体角针 1/2 17 PE35TC004 0 90 绿色、白色圆体角针 1/2 12

Approval Department

Beijing Municipal Drug Administration

北京市药品监督管理局

Registration Information

Registration Number

京械注准20232020107

Approval Date

March 07, 2023

Expiry Date

March 06, 2028

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

The third floor of Building 1, No. 28 Torch Street, Science and Technology Park, Changping District, Beijing

北京市昌平区科技园区火炬街28号1号楼三层

Production Facility

Production Address

北京市昌平区科技园区火炬街28号，北京市昌平区北七家镇上承路8号A区，北京市朝阳区金盏大姐西路白桥工业区西侧2号

Structure and Composition

English

It consists of sutures and suture needles. Among them, the suture is a multi-stranded suture made of polyethylene terephthalate, coated with polysilicone ether coating, stained by (D&C green No. 6 C161565) dye, divided into green and white (no staining) two types. The suture needle is divided into round needle and round angle needle, and the material is 30Cr13 stainless steel. The product is sterilized by ethylene oxide, single-use, sterilization validity period of 5 years.

中文

由缝合线和缝合针组成。其中缝合线是由聚对苯二甲酸乙二醇酯制成的多股缝线，表面涂覆有聚硅醚涂层，经（D&C绿色6号C161565）染色剂染色，分为绿色和白色（无染色）两种。缝合针分为圆针和圆体角针，材质为30Cr13不锈钢。产品经环氧乙烷灭菌，一次性使用，灭菌有效期5年。

Storage Conditions and Expiration

English

5 years

中文

5年

Additional Information

Appendix

产品技术要求