Dover

Female Urinary Specimen Catheter KIT, 15 ML Tube W/Flip CAP, Prep Components, 8 FR (2.7 MM)

Registry build 21.09.26
21manufacturers in China registered for this device type
2catalogue numbers in this listing

Who Else Makes It

Concentrated in Jiangsu (9), Zhejiang (7), Shanghai (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code EZD
Manufacturer City Province Registered as Device types
Conod Medical Co., Limited Changshu Jiangsu Contract manufacturer 48
Well Lead Medical Co., Ltd. Guangzhou Guangdong Contract manufacturer 46
Conod Medical Shuyang Co., Ltd. Shuyang Jiangsu Contract manufacturer 22
Suzhou Jingle Polymer Medical Apparatus Co., Ltd. Suzhou Jiangsu Contract manufacturer 19
Haiyan Kangyuan Medical Instrument Co., Ltd. Jiaxing Zhejiang Contract manufacturer 17
Jiangsu Suyun Medical Materials Co., Ltd. Lianyungang Jiangsu Contract manufacturer 11
Integral Medical Products Co., Ltd. Shaoxing Zhejiang Contract manufacturer 7
Shaoxing Fuqing Health Products Co., Ltd. Shaoxing Zhejiang Contract manufacturer 3
Xianju Bever Medical Devices Co., Ltd. Taizhou Zhejiang Contract manufacturer 3
Sterigenics Shanghai ETO Ltd. Shanghai Shanghai Contract manufacturer 65
Amsino Medical (Kunshan) Co., Ltd. Kunshan Jiangsu Contract manufacturer 53
Changshu Rozer Sterilization Technology Co., Ltd. Changshu Jiangsu Contract manufacturer 43

Showing 12 of 21. All 21 manufacturers in China registered for Catheter, Straight

Record

Regulatory record for Dover
Listed by Cardinal Health 200, LLC, United States
FDA product code EZD
Device type Catheter, Straight
Device class Class 2
Regulation 21 CFR 876.5130
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Record published 2024-12-20
Record revised 2025-12-31 (version 12)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Supplied sterile Yes
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
Storage Storage environment temperature 15 to 30 °C
Packaging Carton of 25, case of 4
Sizes Catheter gauge 8 Fr
Distribution end date 2025-12-31

Catalogue Numbers

Catalogue numbers for Dover
Catalogue number Size Status
3411 Catheter Gauge 8 Fr In distribution
3411 Catheter Gauge 8 Fr Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Disposable intermittent catheter (TPU Catheter) Chengdu Daxan Innovative Medical Tech. Co., Ltd. 140
LoFric® Hydro-Kit™ Wellspect Healthcare 57
LoFric® Wellspect Healthcare 56
SimPro™ Now Wellspect Healthcare 55
Self-Cath Coloplast A/S 50
Wellead PVC Hydrophilic Urethral Catheter Well Lead Medical Co., Ltd. 50
LoFric® Primo™ Wellspect Healthcare 48
Medline Medline Industries, Inc. 47
Halyard Owens & Minor Distribution, Inc. 39
Cure Catheter Convatec, Purchasing Department 39
AMSure® PVC Intermittent Catheter Amsino Medical Inc. 39
LoFric® Origo™ Wellspect Healthcare 34

Showing 12 of 72. All products under Catheter, Straight

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