Pure Global
国械注准20243141788

Collagen patch dressing

胶原贴敷料
Shandong Zhushi Pharmaceutical Group Co., Ltd.·Class III·NMPA·Approved September 19, 2024
Device classification
Device class
Class III
Model specifications
圆形:φ5cm、φ10cm、φ15cm、φ21.5cm、φ25cm、φ30cm;椭圆形:φ5cm×3cm、φ9.5cm×6cm、φ15cm×10cm、φ20cm×15cm、φ25cm×15cm、φ25cm×20cm、φ30cm×20cm;方形 :10cm×5cm、10cm×10cm、20cm×10cm、40cm×30cm、 40cm×10cm、 60cm×40cm.
圆形：φ5cm、φ10cm、φ15cm、φ21.5cm、φ25cm、φ30cm；椭圆形：φ5cm×3cm、φ9.5cm×6cm、φ15cm×10cm、φ20cm×15cm、φ25cm×15cm、φ25cm×20cm、φ30cm×20cm；方形 ：10cm×5cm、10cm×10cm、20cm×10cm、40cm×30cm、 40cm×10cm、 60cm×40cm。
Approval department
State Drug Administration
国家药品监督管理局
Registration information
Registration number
国械注准20243141788
Approval date
September 19, 2024
Expiry date
September 18, 2029
Registrant
Name
Shandong Zhushi Pharmaceutical Group Co., Ltd.
山东朱氏药业集团有限公司
Province/Region
Shandong
山东
Address
South of Fanlou Road, Shanxian Development Zone
单县开发区樊楼路南
Production facility
Production address
山东单县经济技术开发区食品药品产业园单德路6号
Intended use
English

The product is suitable for the adjuvant treatment of wound repair after laser and photon surgery. The depth of the wound is limited to the superficial epidermis and dermis.

中文

该产品适用于激光、光子术后创面修复辅助治疗。创面深度限于表皮及真皮浅层。

Structure and composition
English

It is composed of type I collagen (0.1%~0.2%), purified water (99.95%~99.7%), potassium sorbate (0.05%~0.1%) and non-woven fabric. The sterilization method of the product is electron beam irradiation sterilization.

中文

由I型胶原蛋白（0.1%~0.2%）、纯化水（99.95%~99.7%）、山梨酸钾（0.05%~0.1%）和无纺布组成。产品灭菌方式为电子束辐照灭菌。

Additional information
Appendix
产品技术要求
About this record

Access comprehensive regulatory information for Collagen patch dressing in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243141788 and owned by Shandong Zhushi Pharmaceutical Group Co., Ltd.. The device was approved on September 19, 2024.

This page provides complete registration details including registrant information, province location (Shandong), 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.