Kegel
Catalogue number HD-05, listed by Star Port Inc, United States, under Dressing, Wound, Hydrogel Without Drug And/Or Biologic. 118 manufacturers in China are registered for this product code.
Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Who Makes This Device Type in China?
118 manufacturers in China hold an FDA registration for this device type, concentrated in Zhejiang, Jiangsu and Guangdong, and 11 other provinces. 16 of them are contract manufacturers, able to build to a buyer’s own specification.
- AID United International Co., Limited Shanghai
- Allmed Medical Products Co., Ltd. Hubei, contract manufacturer
- Anji Spenq Industrial Co., Ltd. Zhejiang
- Anping Guardian Medical Equipment Co., Ltd. Hebei
- Allmed Industrial Limited Guangdong
- Bestreat Safety & First AID Solution Co., Ltd. Hubei
- Bioregen Biomedical (Changzhou) Co., Ltd. Jiangsu, contract manufacturer
- Bluemed Healthcare Co., Ltd. Shanghai
- Boen Healthcare Co., Ltd. Jiangsu
- Beijing Taikesiman Technology Development Co., Ltd. Beijing, contract manufacturer
- Changzhou Hualian Health Dressing Co., Ltd. Jiangsu
- Changzhou Major Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Concarey Medical Technology Co., Ltd. Shanghai
- Dawn Breeze Int'l Trading Limited Hong Kong
- Dongyang City Yonoel Outdoor Products Co., Ltd. Zhejiang, contract manufacturer
- Dongguan City Ruimi Gift Products Co Ltd Guangdong
- Dragon Medical Co., Ltd. Jiangsu, contract manufacturer
- Easting Biomedical Co., Ltd. Guangdong
- Emsrun Group Jiangsu
- Fesun Shanghai Co., Ltd. Shanghai, contract manufacturer
- Firstar Healthcare Company Limited (Guangzhou) Guangdong, contract manufacturer
- Gauke (Hubei) Healthcare Co., Ltd. Hubei, contract manufacturer
- Gauke International Trading Co., Ltd. Hubei
- GFA Production Xiamen Co., Ltd. Fujian
- Guang XI Fulaiming Biopharmaceutics Co., Ltd. Guangxi
- Guangdong Comfort Medical Products Co., Ltd. Guangdong
- Guangdong Tidakang Medical Technology Co., Ltd. Guangdong
- Guangzhou Huada Biotechnology Co., Ltd. Guangdong, contract manufacturer
- Guangzhou Kaiheng K&S Co., Ltd. Guangdong, contract manufacturer
- Guangzhou NEW Design Biotechnology Co., Ltd. Guangdong
- H&K International Trade Limited (China) Zhejiang, contract manufacturer
- Hanghai Medical Products Co Ltd Zhejiang, contract manufacturer
- Hangzhou Rollmed Co., Ltd. Zhejiang, contract manufacturer
- Hebei Houde Hanfang Medical Devices Group Co., Ltd. Hebei
- Henan Chaoya Medical Equipment Co., Ltd. Henan
- Henan Huibo Medical Co., Ltd. Henan, contract manufacturer
- Henso Medical (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
- Hony Medical Co., Ltd. Guangdong, contract manufacturer
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
- Hubei V-Medical Products Co., Ltd. Hubei, contract manufacturer
- Huizhou Foryou Medical Devices Co., Ltd. Guangdong, contract manufacturer
- Heaven Healthcare Co., Ltd. Zhejiang
- Hynaut Health Technology Co., Ltd. Shandong, contract manufacturer
- Jcmed Tianjin Import AND Export Co., Ltd. Tianjin
- Jiangsu Guangyi Medical Dressing Co., Ltd. Jiangsu, contract manufacturer
- Jiangsu Ostup Medical Products Co., Ltd. Jiangsu
- Jiangsu Qiantai Medical Instrument Co., Ltd. Jiangsu, contract manufacturer
- Jiangsu WLD Medical Co., Ltd. Jiangsu, contract manufacturer
- Jiangsu Yizheng Carepro Medical Instruments Co., Ltd. Jiangsu, contract manufacturer
- Jiaoyue Pharmaceutical (Huizhou) Co., Ltd. Guangdong
- Jinzhida Medical (Shanghai) Co., Ltd. Shanghai
- JM Medical Co., Ltd. Shandong, contract manufacturer
- Jiangsu Newvalue Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Medical Distribution Industries, Ltd.
- Nanjing 3H Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Nanjing Anjian Medical Device Co., Ltd. Jiangsu, contract manufacturer
- Nature Health Trading (Hong Kong) Co., Limited Hong Kong
- Ningbo First Import & Export Co., Ltd. Zhejiang
- Ningbo Guangbo Medical Technology Co., Ltd. Zhejiang
- Ningbo Hysent Medical Technology Co., Ltd. Zhejiang
- Ningbo Risenmed Technology Co., Ltd. Zhejiang, contract manufacturer
- Ningbo Tianbo First AID Product Co., Ltd. Zhejiang
- NMS Technologies Jiangsu
- Nanjing J SUN Healthcare Co., Ltd. Jiangsu
- Planet (Anhui) International Co., Ltd. Anhui
- 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
- Rfx+care Manufacturing Co., Ltd. Zhejiang
- Roosin Medical Co., Ltd. Jiangsu, contract manufacturer
- Shandong Kangli Medical Equipment Technology Co., Ltd. Shandong
- Shandong Shinemed Technology Co., Ltd. Shandong, contract manufacturer
- Shandong Zhushi Pharmaceutical Group Co., Ltd. Shandong, contract manufacturer
- Shanghai Dynamic Medical Supplies Co., Ltd. Shanghai, contract manufacturer
- Shanghai Lions Industrial Co., Ltd. Shanghai, contract manufacturer
- Shenzhen Canglv Technology Co., Ltd. Guangdong
- Shenzhen Yuwen E-Commerce Co., Ltd. Guangdong
- Smith & Nephew (Suzhou) Limited Jiangsu, contract manufacturer
- Suzhou Konlida Medical Supplies Co., Ltd. Jiangsu
- Suzhou Pulikang Medical Device Co Ltd Jiangsu
- Suzhou Texnet Jiangsu, contract manufacturer
- Synthetah, LLC Shanghai
- Shanghai Care Us Medical Product Co., Ltd. Shanghai, contract manufacturer
- Shanghai Jolly Industrial Co., Ltd. Shanghai, contract manufacturer
- Shanghai Joy Crown Industry Co., Ltd. Shanghai, contract manufacturer
- Taizhou Chenguang Import AND Export Trading Co., Ltd. Jiangsu
- Tianjin Hodaf Technology Co., Ltd. Tianjin
- Trummed Medical (Hangzhou) Co., Ltd. Zhejiang, contract manufacturer
- Wayson Group Co., Ltd. Guangdong, contract manufacturer
- Wenzhou Baiyu Glasses Technology Co., Ltd. Zhejiang, contract manufacturer
- Winner Medical Co., Ltd. Guangdong
- Wuhan Hangu Technology Co., Ltd. Hubei, contract manufacturer
- Wuhan Huawei Technology Co., Ltd. Hubei, contract manufacturer
- Wuhan Sitaili Medical Apparatus Development Co., Ltd. Hubei
- Waterpulse (Jinhua) Biotechnology Co., Ltd. Zhejiang
- Wenzhou Celecare Medical lnstruments Co., Ltd. Zhejiang
- Wenzhou Scico Medical Corporation Co., Ltd. Zhejiang
- Winner Medical (Jiayu) Co., Ltd. Hubei, contract manufacturer
- Winner Medical (Wuhan) Co., Ltd. Hubei, contract manufacturer
- Xiamen Firstcare IMP. & EXP. Co., Ltd. Fujian
- Yafho BIO-Technology Co., Ltd. Guangdong
- Yiwu EO Sterilization Technology Co., Ltd. Zhejiang, contract manufacturer
- Yiwu Kebon Healthcare Co., Ltd. Zhejiang
- Zhejiang Anji Huabu Industrial Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Aoki Medical Dressing Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Bangli Medical Products Co., Ltd. Zhejiang
- Zhejiang Hangbiao Medical Products Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Huanyi Sterilization Technology Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Kang LI DI Medical Articles Co., Ltd. Zhejiang
- Zhejiang Lidesen Medical Instrument Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Mediunion Healthcare Group Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang TOP-Medical Medical Dressing Co., Ltd. Zhejiang, contract manufacturer
- Zhengzhou Boma Biotech Co., Ltd. Henan, contract manufacturer
- Zhejiang Fitmild Biotechnology Co., Ltd. Zhejiang
- Zhejiang Longterm Medical Technology Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang OneHealth Medical Technology Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Solong Electromechanical Limited Zhejiang, contract manufacturer
How Is NAE Classified?
Dressing, Wound, Hydrogel Without Drug And/Or Biologic is FDA product code NAE, Class 1, 21 CFR 878.4022.
What Does It Take to Sell It in the United States?
It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.
What Do the Recalls Say?
The FDA has recorded 6 recalls under this product code since 2006. None was by a company in China. The root cause the FDA records most often is Process control (4).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Name
Record
Advanced Shield Chronic Wound Care, 2oz
Topical burn and wound dressing, hydrogel barrier antimicrobial with silver,2oz spray HCPCS code A6248
Intrasite Gel Applipak 15g USA Ctn 10
Catalogue number 66027311, listed by Smith & Nephew, Inc., United States, under Dressing, Wound, Hydrogel Without Drug And/Or Biologic. 118 manufacturers in China are registered for this product code.
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