Celling Biosciences Versatile Delivery Kit
Catalogue number 0861-0003, listed by Micromedics, Inc., United States, under Syringe, Irrigating (Non Dental). 110 manufacturers in China are registered for this product code.
Syringe, Irrigating (Non Dental)
Which Manufacturers in China Make This?
110 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Guangdong and Zhejiang, and 9 other provinces. 20 of them are contract manufacturers, able to build to a buyer’s own specification.
- Aena Medical (Jiangsu) Co., Ltd. Jiangsu, contract manufacturer
- Amsino Medical (Kunshan) Co., Ltd. Jiangsu, contract manufacturer
- Amsino Medical (Shanghai) Co., Ltd. Shanghai, contract manufacturer
- Anhui Easyway Medical Supplies Co., Ltd. Anhui
- Anhui Yixiang Trading Co., Ltd. Anhui
- Anji Spenq Industrial Co., Ltd. Zhejiang
- Aimi Health Technology (Guangdong) Co., Ltd. Guangdong
- Apex (Guangzhou) Tools & Orthopedics Company Guangdong, contract manufacturer
- BH Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Biomed Plastics Co. Jiangsu, contract manufacturer
- Boen Healthcare Co., Ltd. Jiangsu
- Changshu Rozer Sterilization Technology Co., Ltd. Jiangsu, contract manufacturer
- Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. Sichuan, contract manufacturer
- China (Shenyang) MED-Land IMP/EXP Corp., Ltd. Shanghai
- Cotronic Technology Limited Guangdong, contract manufacturer
- Conod Medical Co., Limited Jiangsu, contract manufacturer
- Dongguan Yanxi Technology Co., Ltd. Guangdong, contract manufacturer
- Dongguan City Ruimi Gift Products Co Ltd Guangdong
- Dongguan Qing Xi Essentia Industries Ltd Guangdong
- Elung Industrial Co., Ltd. Hong Kong
- Exact Medical Manufacturing, Inc. Jiangsu, contract manufacturer
- Essentia Industries Ltd. Guangdong, contract manufacturer
- Fesun Shanghai Co., Ltd. Shanghai, contract manufacturer
- Firstar Healthcare Company Limited (Guangzhou) Guangdong, contract manufacturer
- Foshan City Shunde Jiajun Plastic & Hardware Products Co Ltd Guangdong, contract manufacturer
- Gcmedica Enterprise Ltd.(Wuxi) Jiangsu, contract manufacturer
- GFA Production Xiamen Co., Ltd. Fujian
- GRI Medical & Electronic Technology Co., Ltd. Zhejiang, contract manufacturer
- Guangdong Kindly Medical Device Group Co., Ltd. Guangdong, contract manufacturer
- Guangzhou Baoli Hardware & Electronic Co., Ltd. Guangdong, contract manufacturer
- Guangdong Okay Technology Co., Ltd. Guangdong
- Hangzhou Weize IMP & EXP Co., Ltd. Zhejiang
- Henan Aile Industrial Co., Ltd. Henan, contract manufacturer
- Hospital & Homecare IMP. & EXP. Co., Ltd. Jiangsu, contract manufacturer
- Huzhou Junda Industry Co., Ltd. Zhejiang, contract manufacturer
- Hangzhou Primecare Medical Co., Ltd. Zhejiang, contract manufacturer
- Inmed (Wuxi) Medical Device Co., Ltd. Jiangsu
- Jiangsu Caina Medical Co., Ltd. Jiangsu, contract manufacturer
- Jiangsu Kangbao Medical Equipment Co., Ltd. Jiangsu, contract manufacturer
- Jiangsu Micsafe Medical Technology Co., Ltd. Jiangsu
- Jiangsu NEW Pentastar Medical Products Co., Ltd. Jiangsu
- Jiangsu Senwo Medical Technology Co., Ltd. Jiangsu, contract manufacturer
- Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. Jiangsu, contract manufacturer
- Jiangyin Nanquan Macromolecule Product Co., Ltd. Jiangsu, contract manufacturer
- Joykey Industrial (Pinghu) Limited Zhejiang, contract manufacturer
- Jumin BIO-Technologies, Co., Ltd. Shanghai, contract manufacturer
- JWD. Technologies (Jiangmen) Co., Ltd. Guangdong
- KOO Medical Equipment (Shanghai) Co., Ltd. Shanghai, contract manufacturer
- Koo (Shanghai) Industries Co., Ltd. Shanghai, contract manufacturer
- Laerdal Medical (Suzhou) Co., Ltd.
- Lian XIN Toys Ltd Guangdong, contract manufacturer
- Lianyungang Aoke Medical Equipment Co., Ltd. Jiangsu
- Linhai Deyi Plastic Co., Ltd. Zhejiang, contract manufacturer
- Medcodes Healthcare (Shenzhen) Limited Guangdong
- Medico Industries & Trade Co., Ltd. Hebei
- Nanning Sixtant Biotechnology Co., Ltd. Guangxi
- Ningbo Albert Novosino Co., Ltd. Zhejiang, contract manufacturer
- Ningbo First Import & Export Co., Ltd. Zhejiang
- Ningbo Tianbo First AID Product Co., Ltd. Zhejiang
- Ningbo Yingmed Medical Instruments Co., Ltd. Zhejiang
- Ningbo Greatcare Medical Instruments Co., Ltd. Zhejiang, contract manufacturer
- PRO-MED (Wuxi)IMP.& Exp.co., Ltd. Jiangsu
- Promisemed Hangzhou Meditech Co., Ltd. Zhejiang, contract manufacturer
- Primecare Medical (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
- Principle & Will Biotech (Pinghu) Co., Ltd. Zhejiang, contract manufacturer
- Rozer Sterilization Technology Shuyang Company Limited Jiangsu, contract manufacturer
- Shandong Zhushi Pharmaceutical Group Co., Ltd. Shandong, contract manufacturer
- Shanghai Huihu Medical Appliance Co., Ltd. Shanghai
- Shanghai Lejoy Co., Ltd. Shanghai
- Shanghai NEO-Medical Import & Export Co., Ltd. Shanghai
- Shantou Wealy Medical Instrument Co., Ltd. Guangdong, contract manufacturer
- Shaoxing Haitech Medical Products Co., Ltd. Zhejiang
- Shengzhou Kingbird Travel Products Co., Ltd. Zhejiang
- Shenzhen Baria Technology Co., Ltd. Guangdong
- Shenzhen Kingboom Technology Co., Ltd. Guangdong
- Shenzhen Mlikang Technology Co., Ltd. Guangdong, contract manufacturer
- Shenzhen Moye Technology Co Ltd Guangdong, contract manufacturer
- Shun SZE Industrial (Shenzhen) Co., Ltd. Guangdong, contract manufacturer
- Singgao Precision Technology (Dongguan) Co., Ltd. Guangdong, contract manufacturer
- Steris Sterilization Technologies (Suzhou) Ltd Jiangsu, contract manufacturer
- Sunmed AP, Ltd. Guangdong, contract manufacturer
- Sunmed AP, Ltd., Warehouse NO. 2 Guangdong, contract manufacturer
- Suzhou Acmed Import & Export Co., Ltd. Jiangsu
- Suzhou Hengxiang IMP. & EXP. Co., Ltd. Jiangsu
- Suzhou Jingle Polymer Medical Apparatus Co., Ltd. Jiangsu, contract manufacturer
- Suzhou Jinsheng Plastic Co., Ltd. Jiangsu, contract manufacturer
- Suzhou Pipi Medical Products Co., Ltd. Jiangsu, contract manufacturer
- Suzhou Prosteri Medical Technology Co., Ltd. Jiangsu, contract manufacturer
- Shanghai Xodus Medical Company Limited Shanghai
- Smart Technology Co., Ltd. Guangdong
- Sterigenics Shanghai ETO Ltd. Shanghai, contract manufacturer
- Ucomfor Medical Co., Ltd. Shanghai
- Ucomfor Scientific Co., Ltd. Jiangsu, contract manufacturer
- Vastrade Manufacturing Corporation Guangdong, contract manufacturer
- Wenzhou Zuoyou Medical Technoloyg Co., Ltd. Zhejiang, contract manufacturer
- Wttod (Shanghai) Life Science Ltd. Shanghai
- Weihai Hongyu Nonwoven Fabric Products Co., Ltd. Shandong, contract manufacturer
- Xiamen Jieboya Technology Co., Ltd. Fujian, contract manufacturer
- Xiamen Longzhiyuan Plastic Co., Ltd. Fujian
- Yangzhou Medline Industry Co., Ltd. Jiangsu, contract manufacturer
- Zhejiang Aicor Medical Technology Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Anji Huabu Industrial Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Haisheng Medical Device Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Hope Pharma Ltd Zhejiang, contract manufacturer
- Zhejiang Huanyi Sterilization Technology Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Lidesen Medical Instrument Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Longde Pharmaceutical Co., Ltd. Zhejiang, contract manufacturer
- Zhejiang Medicines & Health Products I/ E Co., Ltd. Zhejiang
- Zhejiang Mediunion Healthcare Group Co., Ltd. Zhejiang, contract manufacturer
- Zhuhai Longtime Biological Technology Co., Ltd. Guangdong
How Is KYZ Classified?
Syringe, Irrigating (Non Dental) is FDA product code KYZ, Class 1, 21 CFR 880.6960.
How Does It Reach the US Market?
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. It is also exempt from most of the quality system regulation.
What Has Gone Wrong With It?
The FDA has recorded 20 recalls under this product code since 2009. None was by a company in China. 1 is Class I, the most serious grade.
The root causes the FDA records most often are Packaging (5), Process control (5) and Packaging process control (3). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.
Name
Record
Custom Select Piston Irrigation Tray
Custom Select Piston Irrigation Tray, with 70cc Piston Syringe
SOL-M™ Catheter Tip Syringe W/o Needle
SOL-M 60ml Catheter Tip Syringe w/o Needle
Mckesson
Catalogue number 37-234, listed by Nurse Assist, LLC, United States, under Syringe, Irrigating (Non Dental). 110 manufacturers in China are registered for this product code.
Bardia® Piston Syringe
Catalogue number 802065, listed by C.R. Bard, Inc., United States, under Syringe, Irrigating (Non Dental). 110 manufacturers in China are registered for this product code.