Dressing, Wound, Drug
Which Manufacturers in China Make This?
48 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Guangdong and Hubei, and 8 other provinces. 10 of them are contract manufacturers, able to build to a buyer’s own specification.
- Allmed Medical Products Co., Ltd. Hubei, contract manufacturer
- Amsino Medical (Kunshan) Co., Ltd. Jiangsu, contract manufacturer
- Anji Hongde Medical Products Co., Ltd. Zhejiang, contract manufacturer
- Allmed Industrial Limited Guangdong
- Beijing Kreate Medical Co., Ltd. Beijing
- Changzhou Major Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Cardinal Medical Equipment Consulting (Shanghai)Co., Ltd. Shanghai
- Derma Sciences Nantong Incorporation Jiangsu, contract manufacturer
- Dongguan Shin YI Healthcare Products Factory Guangdong, contract manufacturer
- Foshan United Medical Technologies Ltd. Guangdong, contract manufacturer
- Guang XI Fulaiming Biopharmaceutics Co., Ltd. Guangxi
- Guang Zhou Medclear Medical Device Service Co., Ltd. Guangdong, contract manufacturer
- Guangzhou Kaiheng K&S Co., Ltd. Guangdong, contract manufacturer
- Hubei V-Medical Products Co., Ltd. Hubei, contract manufacturer
- Huizhou Foryou Medical Devices Co., Ltd. Guangdong, contract manufacturer
- HongYu BioTech (ShenZhen) Co., Ltd. Guangdong, contract manufacturer
- Jcmed Tianjin Import AND Export Co., Ltd. Tianjin
- Jianerkang Medical Co., Ltd. Jiangsu, contract manufacturer
- Jiangsu NEW Pentastar Medical Products Co., Ltd. Jiangsu
- Jinhua Jingdi Medical Supplies Co., Ltd. Zhejiang, contract manufacturer
- Lucky Star Lrradiation Science Co., Ltd. Shanghai Shanghai, contract manufacturer
- Nanjing Anjian Medical Device Co., Ltd. Jiangsu, contract manufacturer
- Planet (Anhui) Medical Products Co., Ltd. Anhui, contract manufacturer
- Planet(Shanghai) International Co., Ltd. Shanghai
- Polyzon Sciences Co., Ltd. Shanghai, contract manufacturer
- Qingdao Bright Moon Biomedical Materials Co Ltd Shandong
- Roosin Medical Co., Ltd. Jiangsu, contract manufacturer
- Shanghai JPY ION-Tech Co., Ltd. Shanghai, contract manufacturer
- Shanghai Mebo Life Science & Technology Co., Ltd. Shanghai, contract manufacturer
- Shenzhen JPY ION-Tech. Co., Ltd. Guangdong, contract manufacturer
- Smith & Nephew (Suzhou) Limited Jiangsu, contract manufacturer
- Suzhou Avon Textile Co., Ltd. Jiangsu, contract manufacturer
- Suzhou Sunmed Co., Ltd. Jiangsu, contract manufacturer
- Suzhou Vicon Industrial Co., Ltd. Jiangsu, contract manufacturer
- Sterigenics Shanghai ETO Ltd. Shanghai, contract manufacturer
- Suzhou Cnnc Huadong Radiation Co., Ltd. Jiangsu, contract manufacturer
- Taizhou Chenguang Import AND Export Trading Co., Ltd. Jiangsu
- Taizhou Xinkang Medical Materials Co., Ltd. Jiangsu, contract manufacturer
- Winner Medical Co., Ltd. Guangdong
- Winner Medical (Chongyang) Co., Ltd. Hubei, contract manufacturer
- Winner Medical (Huanggang) Co., Ltd. Hubei, contract manufacturer
- Winner Medical (Jiayu) Co., Ltd. Hubei, contract manufacturer
- Winner Medical (Wuhan) Co., Ltd. Hubei, contract manufacturer
- Xiamen Firstcare IMP. & EXP. Co., Ltd. Fujian
- Zhangjiagang Municipal Cnnc Huakang Radiation Co., Ltd. Jiangsu, contract manufacturer
- Zhejiang Excellent United Medical Technology Co., Ltd. Zhejiang, contract manufacturer
- Zhongjin Irradiation Wuhan Co., Ltd. Hubei, contract manufacturer
- Zhejiang Longterm Medical Technology Co., Ltd. Zhejiang, contract manufacturer
How Is FRO Classified?
Dressing, Wound, Drug is FDA product code FRO, unclassified.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 43 clearances under this code; the FDA took a median of 262 days from receipt to decision on them. 3 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.
What Has Gone Wrong With It?
The FDA has recorded 82 recalls under this product code since 2004. None was by a company in China. 3 are Class I, the most serious grade.
The root causes the FDA records most often are Process control (9), No Marketing Application (8) and Environmental control (8). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.