Folysil
47 catalogue numbers from AA6424, listed by Coloplast A/S, Denmark, under Catheter, Retention Type, Balloon. 17 manufacturers in China are registered for this product code.
17manufacturers in China registered for this device type
47catalogue 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 | 2024-07-12 |
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: Keep away from rain. Keep away from sunlight. Do not use if package is damaged and consult IFU. Do not resterilize. |
| Packaging | Retail box of 5, shipper box of 27 |
| Sizes | Catheter gauge 6 to 24 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AA6424 | Catheter Gauge 24 Fr | In distribution |
| AA6308 | Catheter Gauge 8 Fr | In distribution |
| AA6522 | Catheter Gauge 22 Fr | In distribution |
| AA6614 | Catheter Gauge 14 Fr | In distribution |
| AA6612 | Catheter Gauge 12 Fr | In distribution |
| AA6406 | Catheter Gauge 6 Fr | In distribution |
| AA6318 | Catheter Gauge 18 Fr | In distribution |
| AA6524 | Catheter Gauge 24 Fr | In distribution |
| AA6518 | Catheter Gauge 18 Fr | In distribution |
| AA6116 | Catheter Gauge 16 Fr | In distribution |
| AA6420 | Catheter Gauge 20 Fr | In distribution |
| AA6314 | Catheter Gauge 14 Fr | In distribution |
| AA6C18 | Catheter Gauge 18 Fr | In distribution |
| AA6C22 | Catheter Gauge 22 Fr | In distribution |
| AA6512 | Catheter Gauge 12 Fr | In distribution |
| AA6124 | Catheter Gauge 24 Fr | In distribution |
| AA6412 | Catheter Gauge 12 Fr | In distribution |
| AA6310 | Catheter Gauge 10 Fr | In distribution |
| AA6C20 | Catheter Gauge 20 Fr | In distribution |
| AA6414 | Catheter Gauge 14 Fr | In distribution |
| AA6122 | Catheter Gauge 22 Fr | In distribution |
| AA6108 | Catheter Gauge 8 Fr | In distribution |
| AA6110 | Catheter Gauge 10 Fr | In distribution |
| AA6316 | Catheter Gauge 16 Fr | In distribution |
| AA6616 | Catheter Gauge 16 Fr | In distribution |
| AA6114 | Catheter Gauge 14 Fr | In distribution |
| AA6C24 | Catheter Gauge 24 Fr | In distribution |
| AA6620 | Catheter Gauge 20 Fr | In distribution |
| AA6618 | Catheter Gauge 18 Fr | In distribution |
| AA6408 | Catheter Gauge 8 Fr | In distribution |
| AA6514 | Catheter Gauge 14 Fr | In distribution |
| AA6410 | Catheter Gauge 10 Fr | In distribution |
| AA6106 | Catheter Gauge 6 Fr | In distribution |
| AA6624 | Catheter Gauge 24 Fr | In distribution |
| AA6622 | Catheter Gauge 22 Fr | In distribution |
| AA6422 | Catheter Gauge 22 Fr | In distribution |
| AA6312 | Catheter Gauge 12 Fr | In distribution |
| AA6516 | Catheter Gauge 16 Fr | In distribution |
| AA6418 | Catheter Gauge 18 Fr | In distribution |
| AA6416 | Catheter Gauge 16 Fr | In distribution |
| AA6520 | Catheter Gauge 20 Fr | In distribution |
| AA6324 | Catheter Gauge 24 Fr | In distribution |
| AA6322 | Catheter Gauge 22 Fr | In distribution |
| AA6120 | Catheter Gauge 20 Fr | In distribution |
| AA6118 | Catheter Gauge 18 Fr | In distribution |
| AA6112 | Catheter Gauge 12 Fr | In distribution |
| AA6320 | Catheter Gauge 20 Fr | In distribution |
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 |
| Porges Coloplast | Coloplast A/S | 74 |
| Medline | Medline Industries, Inc. | 72 |
| McKesson | Mckesson Medical-Surgical Inc. | 63 |
| TruCath | HR Pharmaceuticals Inc. | 59 |
| 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.