Porges Coloplast
X-FLOW® Prostatectomy catheter Couvelaire tip 2-way 30-50 ml 100% silicone CH FR 24
17manufacturers in China registered for this device type
74catalogue 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.
| 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
| Listed by | Coloplast A/S, Denmark |
|---|---|
| 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 | 2016-08-01 |
| Record revised | 2024-10-07 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store away from light in a cool and dry place |
| Packaging | Retail box of 5 |
| Sizes | Catheter gauge 6 to 24 Fr |
| Distribution end date | 2024-07-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AB6420 | Catheter Gauge 20 Fr | In distribution |
| AB6A22 | Catheter Gauge 22 Fr | In distribution |
| AB6524 | Catheter Gauge 24 Fr | In distribution |
| AA6310 | Catheter Gauge 10 Fr | In distribution |
| AB6020 | Catheter Gauge 20 Fr | In distribution |
| AB6522 | Catheter Gauge 22 Fr | In distribution |
| AB6022 | Catheter Gauge 22 Fr | In distribution |
| AB6418 | Catheter Gauge 18 Fr | In distribution |
| AA6120 | Catheter Gauge 20 Fr | In distribution |
| AA6C18 | Catheter Gauge 18 Fr | In distribution |
| AB6A20 | Catheter Gauge 20 Fr | In distribution |
| AB6720 | Catheter Gauge 20 Fr | In distribution |
| AB6A24 | Catheter Gauge 24 Fr | In distribution |
| AA6308 | Catheter Gauge 8 Fr | In distribution |
| AB6122 | Catheter Gauge 22 Fr | In distribution |
| AA6318 | Catheter Gauge 18 Fr | In distribution |
| AA6C20 | Catheter Gauge 20 Fr | In distribution |
| AA6414 | Catheter Gauge 14 Fr | In distribution |
| AA6118 | Catheter Gauge 18 Fr | In distribution |
| AA6820 | Catheter Gauge 20 Fr | In distribution |
| AB6320 | Catheter Gauge 20 Fr | In distribution |
| AB6118 | Catheter Gauge 18 Fr | In distribution |
| AA6410 | Catheter Gauge 10 Fr | In distribution |
| AB6C22 | Catheter Gauge 22 Fr | In distribution |
| AB6318 | Catheter Gauge 18 Fr | In distribution |
| AA6416 | Catheter Gauge 16 Fr | In distribution |
| AA6408 | Catheter Gauge 8 Fr | In distribution |
| AA6110 | Catheter Gauge 10 Fr | In distribution |
| AA6322 | Catheter Gauge 22 Fr | In distribution |
| AA6114 | Catheter Gauge 14 Fr | In distribution |
| AA6C22 | Catheter Gauge 22 Fr | In distribution |
| AA6418 | Catheter Gauge 18 Fr | In distribution |
| AB6018 | Catheter Gauge 18 Fr | In distribution |
| AA6422 | Catheter Gauge 22 Fr | In distribution |
| AB6422 | Catheter Gauge 22 Fr | In distribution |
| AA6324 | Catheter Gauge 24 Fr | In distribution |
| AB6220 | Catheter Gauge 20 Fr | In distribution |
| AA6312 | Catheter Gauge 12 Fr | In distribution |
| AA6424 | Catheter Gauge 24 Fr | In distribution |
| AB6024 | Catheter Gauge 24 Fr | In distribution |
| AB6324 | Catheter Gauge 24 Fr | In distribution |
| AB6424 | Catheter Gauge 24 Fr | In distribution |
| AA6112 | Catheter Gauge 12 Fr | In distribution |
| AA6316 | Catheter Gauge 16 Fr | In distribution |
| AB6C24 | Catheter Gauge 24 Fr | In distribution |
| AB6322 | Catheter Gauge 22 Fr | In distribution |
| AB6218 | Catheter Gauge 18 Fr | In distribution |
| AB6520 | Catheter Gauge 20 Fr | In distribution |
| AA6106 | Catheter Gauge 6 Fr | In distribution |
| AA6822 | Catheter Gauge 22 Fr | In distribution |
| AB6C20 | Catheter Gauge 20 Fr | In distribution |
| AA6122 | Catheter Gauge 22 Fr | In distribution |
| AA6314 | Catheter Gauge 14 Fr | In distribution |
| AA6320 | Catheter Gauge 20 Fr | In distribution |
| AA6420 | Catheter Gauge 20 Fr | In distribution |
| AA6412 | Catheter Gauge 12 Fr | In distribution |
| AA6C24 | Catheter Gauge 24 Fr | In distribution |
| AB6A18 | Catheter Gauge 18 Fr | In distribution |
| AA6108 | Catheter Gauge 8 Fr | In distribution |
| AB6C18 | Catheter Gauge 18 Fr | In distribution |
| AA6116 | Catheter Gauge 16 Fr | In distribution |
| AA6124 | Catheter Gauge 24 Fr | In distribution |
| AB6224 | Catheter Gauge 24 Fr | In distribution |
| AB6120 | Catheter Gauge 20 Fr | In distribution |
| AB6518 | Catheter Gauge 18 Fr | In distribution |
| AB6222 | Catheter Gauge 22 Fr | In distribution |
| AB6124 | Catheter Gauge 24 Fr | In distribution |
| AB6724 | Catheter Gauge 24 Fr | Withdrawn |
| AB6622 | Catheter Gauge 22 Fr | Withdrawn |
| AB6722 | Catheter Gauge 22 Fr | Withdrawn |
| AB6624 | Catheter Gauge 24 Fr | Withdrawn |
| AB6618 | Catheter Gauge 18 Fr | Withdrawn |
| AB6620 | Catheter Gauge 20 Fr | Withdrawn |
| AB6718 | Catheter Gauge 18 Fr | Withdrawn |
Same 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 |
| 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 |
| AMSure® Silicone Coated Latex Foley Catheter | Amsino Medical Inc. | 28 |
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.