Self-Cath
Self-Cath®. Urinary Catheter. Straight Tip without connector Female . Catheter Gauge 14 FR/CH, Diameter 4.7 mm.
21manufacturers in China registered for this device type
50catalogue 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 |
| 510(k) | K100878 |
| Record published | 2016-09-02 |
| Record revised | 2024-10-14 (version 6) |
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 | Shipper box of 12, retail box of 30, retail box of 50, shipper box of 360 |
| Sizes | Catheter gauge 5 to 18 Fr; catheter working length 4.8 to 14.9 in; catheter working length 12 to 38 cm; outer diameter 4.7 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50221 / 450 | Catheter Gauge 14 Fr | In distribution |
| 50475 / 816 | Catheter Gauge 16 Fr | In distribution |
| 50473 / 812 | Catheter Gauge 12 Fr | In distribution |
| 50183 / 116 | Catheter Gauge 16 Fr | In distribution |
| 50476 / 818 | Catheter Gauge 18 Fr | In distribution |
| 50451 / 410 | Catheter Gauge 10 Fr | In distribution |
| 50221 / 450 | Catheter Gauge 14 Fr | In distribution |
| 50181 / 112 | Catheter Gauge 12 Fr | In distribution |
| 50462 / 212 | Catheter Gauge 12 Fr | In distribution |
| 50473 / 812 | Catheter Gauge 12 Fr | In distribution |
| 50196 / 240 | Catheter Gauge 14 Fr | In distribution |
| 50451 / 410 | Catheter Gauge 10 Fr | In distribution |
| 50196 | Outer Diameter 4.7 mm | In distribution |
| 50466 / 610 | Catheter Gauge 10 Fr | In distribution |
| 50203 | Catheter Gauge 14 Fr | In distribution |
| 50474 / 814 | Catheter Gauge 14 Fr | In distribution |
| 50182 / 114 | Catheter Gauge 14 Fr | In distribution |
| 50452 / 412 | Catheter Gauge 12 Fr | In distribution |
| 50463 / 214 | Catheter Gauge 14 Fr | In distribution |
| 50472 / 810 | Catheter Gauge 10 Fr | In distribution |
| 50450 / 408 | Catheter Gauge 8 Fr | In distribution |
| 50196 / 240 | Catheter Gauge 14 Fr | In distribution |
| 50440 / 305 | Catheter Gauge 5 Fr | In distribution |
| 50180 / 110 | Catheter Gauge 10 Fr | In distribution |
| 50204 | Catheter Gauge 16 Fr | In distribution |
| 50181 / 112 | Catheter Gauge 12 Fr | In distribution |
| 50220 / 460 | Catheter Gauge 12 Fr | In distribution |
| 50442 / 308 | Catheter Gauge 8 Fr | In distribution |
| 50443 / 310 | Catheter Gauge 10 Fr | In distribution |
| 50455 / 418 | Catheter Gauge 18 Fr | In distribution |
| 50467 / 612 | Catheter Gauge 12 Fr | In distribution |
| 50462 / 212 | Catheter Gauge 12 Fr | In distribution |
| 50183 / 116 | Catheter Gauge 16 Fr | In distribution |
| 50460 / 208 | Catheter Gauge 8 Fr | In distribution |
| 50201 | Catheter Gauge 16 Fr | In distribution |
| 50468 / 614 | Catheter Gauge 14 Fr | In distribution |
| 50453 / 414 | Catheter Gauge 14 Fr | In distribution |
| 50453 / 414 | Catheter Gauge 14 Fr | In distribution |
| 50202 | Catheter Gauge 14 Fr | In distribution |
| 50455 / 418 | Catheter Gauge 18 Fr | In distribution |
| 50220 / 460 | Catheter Gauge 12 Fr | In distribution |
| 50465 / 608 | Catheter Gauge 8 Fr | In distribution |
| 50470 / 806 | Catheter Gauge 6 Fr | In distribution |
| 50182 / 114 | Catheter Gauge 14 Fr | In distribution |
| 50471 / 808 | Catheter Gauge 8 Fr | In distribution |
| 50452 / 412 | Catheter Gauge 12 Fr | In distribution |
| 50461 / 210 | Catheter Gauge 10 Fr | In distribution |
| 50441 / 306 | Catheter Gauge 6 Fr | In distribution |
| 50454 / 416 | Catheter Gauge 16 Fr | In distribution |
| 50463 / 214 | Catheter Gauge 14 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 |
| 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 |
| PVC Hydrophilic Urethral Catheter | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 32 |
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.