Disposable Intermittent Catheter (TPU Catheter)
Daxan Disposable Intermittent TPU Catheter is a single-use tube for draining urine from the bladder through the urethra. The range includes pediatric and adult, male and female…
Daxan Disposable Intermittent TPU Catheter is a single-use tube for draining urine from the bladder through the urethra. The range includes pediatric and adult, male and female configurations.
The catheter body is thermoplastic polyurethane. Coated versions use a polyvinylpyrrolidone hydrophilic surface, while uncoated versions provide the catheter without that surface layer.
Listed Item
Ready-to-use type,pediatric female type, Catheter OD.06Fr, coated TPU catheter
Preparation Presentations
Water-sachet models include sterile water, and ready-to-use models are packaged with a small amount of saline. Coated normal models have no added fluid accessory. The sterile range is intended for use lasting no more than 24 hours, with pediatric use specified above two years of age.
21manufacturers in China registered for this device type
140catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Chengdu Daxan Innovative Medical Tech. Co., Ltd., China |
|---|---|
| FDA product code | EZD |
| Device type | Catheter, Straight |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Manufacturer |
| 510(k) | K243175 |
| Record published | 2026-06-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| H09-12WS | 30 | In distribution | |
| H09-16W | 30 | In distribution | |
| H09-20FU | 30 | In distribution | |
| H09-24F | 30 | In distribution | |
| H09-10MS | 30 | In distribution | |
| H11-T-06PM | 30 | In distribution | |
| H11-T-08M | 30 | In distribution | |
| H11-T-20F | 30 | In distribution | |
| H09-08PMU | 30 | In distribution | |
| H11-T-16M | 30 | In distribution | |
| H09-08PFU | 30 | In distribution | |
| H09-24MS | 30 | In distribution | |
| H09-16FU | 30 | In distribution | |
| H09-14M | 30 | In distribution | |
| H09-10PM | 30 | In distribution | |
| H11-T-10M | 30 | In distribution | |
| H11-T-14W | 30 | In distribution | |
| H09-10PFU | 30 | In distribution | |
| H11-T-06PF | 30 | In distribution | |
| H09-18F | 30 | In distribution | |
| H09-18MS | 30 | In distribution | |
| H09-20F | 30 | In distribution | |
| H09-12PFS | 30 | In distribution | |
| H09-06PMS | 30 | In distribution | |
| H09-16MS | 30 | In distribution | |
| H09-12FU | 30 | In distribution | |
| H09-20WS | 30 | In distribution | |
| H09-10FU | 30 | In distribution | |
| H09-08MU | 30 | In distribution | |
| H09-12PM | 30 | In distribution | |
| H09-14MU | 30 | In distribution | |
| H09-22MS | 30 | In distribution | |
| H09-12FS | 30 | In distribution | |
| H09-20W | 30 | In distribution | |
| H09-12PMS | 30 | In distribution | |
| H09-20FS | 30 | In distribution | |
| H09-08W | 30 | In distribution | |
| H09-22M | 30 | In distribution | |
| H11-T-22F | 30 | In distribution | |
| H11-T-12M | 30 | In distribution | |
| H09-20MU | 30 | In distribution | |
| H11-T-12PM | 30 | In distribution | |
| H11-T-18W | 30 | In distribution | |
| H09-08WU | 30 | In distribution | |
| H09-18WU | 30 | In distribution | |
| H09-22WS | 30 | In distribution | |
| H09-24M | 30 | In distribution | |
| H09-24W | 30 | In distribution | |
| H11-T-22W | 30 | In distribution | |
| H09-14WU | 30 | In distribution | |
| H09-18M | 30 | In distribution | |
| H09-24WU | 30 | In distribution | |
| H11-T-08F | 30 | In distribution | |
| H09-20WU | 30 | In distribution | |
| H09-12W | 30 | In distribution | |
| H11-T-08PF | 30 | In distribution | |
| H09-12MU | 30 | In distribution | |
| H09-12F | 30 | In distribution | |
| H09-10M | 30 | In distribution | |
| H11-T-12PF | 30 | In distribution | |
| H09-12M | 30 | In distribution | |
| H09-08MS | 30 | In distribution | |
| H09-12WU | 30 | In distribution | |
| H11-T-18M | 30 | In distribution | |
| H09-14FU | 30 | In distribution | |
| H11-T-22M | 30 | In distribution | |
| H09-18WS | 30 | In distribution | |
| H11-T-16F | 30 | In distribution | |
| H11-T-08PM | 30 | In distribution | |
| H09-08PF | 30 | In distribution | |
| H09-06PF | 30 | In distribution | |
| H09-14MS | 30 | In distribution | |
| H11-T-14F | 30 | In distribution | |
| H09-06PMU | 30 | In distribution | |
| H09-22F | 30 | In distribution | |
| H09-20MS | 30 | In distribution | |
| H09-10MU | 30 | In distribution | |
| H09-08F | 30 | In distribution | |
| H09-10PMU | 30 | In distribution | |
| H11-T-24M | 30 | In distribution | |
| H09-14FS | 30 | In distribution | |
| H11-T-10F | 30 | In distribution | |
| H09-14WS | 30 | In distribution | |
| H09-24FU | 30 | In distribution | |
| H11-T-10W | 30 | In distribution | |
| H09-10PMS | 30 | In distribution | |
| H09-10WS | 30 | In distribution | |
| H11-T-20W | 30 | In distribution | |
| H09-16FS | 30 | In distribution | |
| H09-16M | 30 | In distribution | |
| H11-T-16W | 30 | In distribution | |
| H09-24FS | 30 | In distribution | |
| H09-06PFU | 30 | In distribution | |
| H09-16WU | 30 | In distribution | |
| H11-T-20M | 30 | In distribution | |
| H09-06PM | 30 | In distribution | |
| H09-06PFS | 30 | In distribution | |
| H11-T-24F | 30 | In distribution | |
| H09-10F | 30 | In distribution | |
| H09-18FU | 30 | In distribution | |
| H11-T-08W | 30 | In distribution | |
| H09-24MU | 30 | In distribution | |
| H09-10FS | 30 | In distribution | |
| H09-24WS | 30 | In distribution | |
| H11-T-18F | 30 | In distribution | |
| H09-08PMS | 30 | In distribution | |
| H09-18FS | 30 | In distribution | |
| H09-22WU | 30 | In distribution | |
| H09-18W | 30 | In distribution | |
| H09-12PF | 30 | In distribution | |
| H09-08WS | 30 | In distribution | |
| H11-T-14M | 30 | In distribution | |
| H11-T-24W | 30 | In distribution | |
| H09-14W | 30 | In distribution | |
| H09-20M | 30 | In distribution | |
| H09-10W | 30 | In distribution | |
| H09-08FU | 30 | In distribution | |
| H09-10PF | 30 | In distribution | |
| H09-12MS | 30 | In distribution | |
| H09-22FS | 30 | In distribution | |
| H09-08FS | 30 | In distribution | |
| H09-12PMU | 30 | In distribution | |
| H09-18MU | 30 | In distribution | |
| H11-T-10PM | 30 | In distribution | |
| H11-T-12F | 30 | In distribution | |
| H11-T-10PF | 30 | In distribution | |
| H09-08M | 30 | In distribution | |
| H09-14F | 30 | In distribution | |
| H09-16WS | 30 | In distribution | |
| H11-T-12W | 30 | In distribution | |
| H09-12PFU | 30 | In distribution | |
| H09-22FU | 30 | In distribution | |
| H09-10WU | 30 | In distribution | |
| H09-08PFS | 30 | In distribution | |
| H09-10PFS | 30 | In distribution | |
| H09-16F | 30 | In distribution | |
| H09-22MU | 30 | In distribution | |
| H09-16MU | 30 | In distribution | |
| H09-22W | 30 | In distribution | |
| H09-08PM | 30 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K243175 | 2025-06-26 |
| K212567 | 2022-12-07 |
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.