Urological Foley Catheters, Sterile, 22 Fr

2 catalogue numbers from 4942, listed by Dynarex Corp., United States, under Catheter, Retention Type, Balloon. 17 manufacturers in China are registered for this product code.

Registry build 21.09.26
17manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (5), Zhejiang (4), Guangdong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EZL
Manufacturer City Province Registered as Device types
Dongguan BAO Kang Dian ZI KE JI Limited Dongguan Guangdong Contract manufacturer 24
Primecare Medical (Suzhou) Co., Ltd. Changshu Jiangsu Contract manufacturer 20
Haiyan Kangyuan Medical Instrument Co., Ltd. Jiaxing Zhejiang Contract manufacturer 17
Primecare Medical (Huzhou) Co., Ltd. Hu Zhou Zhejiang Contract manufacturer 9
Bioxin Medical Co., Ltd. Weihai Shandong Contract manufacturer 8
Well Lead Medical (Hainan) Co., Ltd. Haikou Hainan Contract manufacturer 3
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Hangzhou Fushan Medical Appliance Co., Ltd. Hangzhou Zhejiang Contract manufacturer 44
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43
Hangzhou Primecare Medical Co., Ltd. Hangzhou Zhejiang Contract manufacturer 29
Amsino Medical (Shanghai) Co., Ltd. Shanghai Shanghai Contract manufacturer 22

Showing 12 of 17. All 17 manufacturers in China registered for Catheter, Retention Type, Balloon

Record

Regulatory record for Urological Foley Catheters, Sterile, 22 Fr
Listed by Dynarex Corp., United States
FDA product code EZL
Device type Catheter, Retention Type, Balloon
Device class Class 2
Regulation 21 CFR 876.5130
Establishment Specification developer, Manufacturer
Record published 2016-09-24
Record revised 2026-05-06 (version 10)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, manufacturing date
Packaging Shipper of 10

Catalogue Numbers

Catalogue numbers for Urological Foley Catheters, Sterile, 22 Fr
Catalogue number Size Per pack Status
4942 10 In distribution
4962 10 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
All Silicone Foley Catheter Well Lead Medical Co., Ltd. 175
Dover Cardinal Health 200, LLC 85
Dover Cardinal Health 82
Rusch Teleflex Medical LLC 79
Porges Coloplast Coloplast A/S 74
Medline Medline Industries, Inc. 72
McKesson Mckesson Medical-Surgical Inc. 63
TruCath HR Pharmaceuticals Inc. 59
Folysil Coloplast A/S 47
Sunmed SunMed Group Holdings, LLC 35
Universa Cook Incorporated 31
AMSure ® Hydrophilic Latex Foley Catheters Amsino Medical Inc. 31

Showing 12 of 135. All products under Catheter, Retention Type, Balloon

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer