Skin repair dressings - NMPA Registration 鲁械注准20242140962

Access comprehensive regulatory information for Skin repair dressings in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20242140962 and owned by Shandong Zhushi Pharmaceutical Group Co., Ltd.. The device was approved on October 30, 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.

Free Database

NMPA Official Data

Class II

鲁械注准20242140962

Skin repair dressings

皮肤修复敷料

NMPA Registration Number: 鲁械注准20242140962

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Pricing

Intended Use

English

喷剂型:用于非慢性创面(如浅表性创面、手术缝合创面、机械创伤、小伤口、擦伤、切割伤、激光/光子/果酸换肤后创面)及周围皮肤的护理; 贴敷型:用于非慢性创面(如浅表性创面、激光/光子/果酸换肤后创面)及周围皮肤的护理.

中文

喷剂型：用于非慢性创面（如浅表性创面、手术缝合创面、机械创伤、小伤口、擦伤、切割伤、激光/光子/果酸换肤后创面）及周围皮肤的护理；贴敷型：用于非慢性创面（如浅表性创面、激光/光子/果酸换肤后创面）及周围皮肤的护理。

Device Classification

Device Class

Class II

Model Specifications

产品型号为喷剂型、贴敷型. 喷剂型的规格根据装量不同分为:5mL、10mL、15mL、20mL、30mL、40mL、50mL、60mL、70mL、80mL、90mL、100mL、120mL、150mL、160mL、180mL、200mL. 贴敷型的规格为:5×5、6×6、7.5×7.5、6×8、7×9、10 × 10、15×15、8×10、5×10、10×20、20×20、20×23、24×21、25×22、Φ2、Φ3、Φ5、Φ7、Φ9、Φ10、Φ15、Φ20、Φ24.

产品型号为喷剂型、贴敷型。喷剂型的规格根据装量不同分为:5mL、10mL、15mL、20mL、30mL、40mL、50mL、60mL、70mL、80mL、90mL、100mL、120mL、150mL、160mL、180mL、200mL。贴敷型的规格为：5×5、6×6、7.5×7.5、6×8、7×9、10 × 10、15×15、8×10、5×10、10×20、20×20、20×23、24×21、25×22、Φ2、Φ3、Φ5、Φ7、Φ9、Φ10、Φ15、Φ20、Φ24。

Approval Department

Shandong Provincial Drug Administration

山东省药品监督管理局

Registration Information

Registration Number

鲁械注准20242140962

Approval Date

October 30, 2024

Expiry Date

October 29, 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

Structure and Composition

English

喷剂型由重组胶原蛋白、己二醇、卡波姆和纯化水组成.贴敷型由重组胶原蛋白、己二醇、卡波姆、纯化水和无纺布组成.

中文

喷剂型由重组胶原蛋白、己二醇、卡波姆和纯化水组成。贴敷型由重组胶原蛋白、己二醇、卡波姆、纯化水和无纺布组成。

Additional Information

Appendix

产品技术要求