Self-Cath Plus
25 catalogue numbers from 50520 / 4808, listed by Coloplast A/S, Denmark, under Catheter, Straight. 21 manufacturers in China are registered for this product code.
21manufacturers in China registered for this device type
25catalogue numbers in this listing
1510(k) clearance
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.
| 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
| Listed by | Coloplast A/S, Denmark |
|---|---|
| FDA product code | EZD |
| Device type | Catheter, Straight |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-09-22 |
| Record revised | 2024-10-14 (version 7) |
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: Do not use if package is damaged and consult IFU. |
| Packaging | Retail box of 30, shipper box of 12 |
| Sizes | Catheter gauge 6 to 18 Fr; catheter working length 4.8 to 14.9 in; catheter working length 12 to 38 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50520 / 4808 | Catheter Gauge 8 Fr | In distribution |
| 50510 / 4608 | Catheter Gauge 8 Fr | In distribution |
| 50303 / 4116 | Catheter Gauge 16 Fr | In distribution |
| 50504 / 4214 | Catheter Gauge 14 Fr | In distribution |
| 50495 / 4418 | Catheter Gauge 18 Fr | In distribution |
| 50492 / 4412 | Catheter Gauge 12 Fr | In distribution |
| 50523 / 4814 | Catheter Gauge 14 Fr | In distribution |
| 50513 / 4614 | Catheter Gauge 14 Fr | In distribution |
| 50522 / 4812 | Catheter Gauge 12 Fr | In distribution |
| 50302 / 4114 | Catheter Gauge 14 Fr | In distribution |
| 50493 / 4414 | Catheter Gauge 14 Fr | In distribution |
| 50481 / 4308 | Catheter Gauge 8 Fr | In distribution |
| 50301 / 4112 | Catheter Gauge 12 Fr | In distribution |
| 50494 / 4416 | Catheter Gauge 16 Fr | In distribution |
| 50490 / 4408 | Catheter Gauge 8 Fr | In distribution |
| 50512 / 4612 | Catheter Gauge 12 Fr | In distribution |
| 50503 / 4212 | Catheter Gauge 12 Fr | In distribution |
| 50521 / 4810 | Catheter Gauge 10 Fr | In distribution |
| 50480 / 4306 | Catheter Gauge 6 Fr | In distribution |
| 50511 / 4610 | Catheter Gauge 10 Fr | In distribution |
| 50524 / 4816 | Catheter Gauge 16 Fr | In distribution |
| 50482 / 4310 | Catheter Gauge 10 Fr | In distribution |
| 50502 / 4210 | Catheter Gauge 10 Fr | In distribution |
| 50491 / 4410 | Catheter Gauge 10 Fr | In distribution |
| 50300 / 4110 | Catheter Gauge 10 Fr | In distribution |
Same 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K262045 | 2026-07-07 |
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.