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Disposable Pulse Irrigator - NMPA Registration 闽械注准20252140029

Access comprehensive regulatory information for Disposable Pulse Irrigator in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 闽械注准20252140029 and owned by Double Medical Technology Inc.. The device was approved on January 14, 2025.

This page provides complete registration details including registrant information, province location (Fujian), 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
闽械注准20252140029
Disposable Pulse Irrigator
一次性脉冲冲洗器
NMPA Registration Number: 闽械注准20252140029
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Pricing
Intended Use
English

用于骨科手术术中与术后对创面和骨髓腔的清洗。.

Device Classification
Device Class
Class II
Model Specifications
PI-Ⅵ、PI-Ⅶ、PI-Ⅷ
Approval Department
Fujian Provincial Drug Administration
福建省药品监督管理局
Registration Information
Registration Number
闽械注准20252140029
Approval Date
January 14, 2025
Expiry Date
January 13, 2030
Registrant
Name
Double Medical Technology Inc.
大博医疗科技股份有限公司
Province/Region
Fujian
福建
Address
No. 18, Hongdong Road, Shanbian District, Haicang District, Xiamen
厦门市海沧区山边洪东路18号
Production Facility
Production Address
厦门市海沧区山边洪东路18号主厂区,18-4号一层A区、二层、三层、四层A区;厦门市海沧区湖头路17-1号一层、三层,17-2号一层A区、二层
Structure and Composition
English

该产品由主机、短喷头、长喷头、毛刷喷头和防溅杯组成。产品经环氧乙烷灭菌,应无菌。.

Additional Information
Appendix
产品技术要求