GentleCath Hydrophilic
Hydrophilic Intermittent Urinary Catheter With Water Sachet Tiemann 16'' 12FR
21manufacturers in China registered for this device type
16catalogue numbers in this listing
4510(k) clearances naming this product code
3recalls on this 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 | Wellspect Healthcare, Sweden |
|---|---|
| FDA product code | EZD |
| Device type | Catheter, Straight |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Record published | 2024-06-01 |
| Record revised | 2024-12-12 (version 5) |
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 |
| Storage | Special storage condition: Keep dry |
| Packaging | Pack of 30, pack of 4 |
| Sizes | Length 8 to 16 in; catheter gauge 8 to 18 Fr |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 509000 | Length 16 in | In distribution |
| 508992 | Catheter Gauge 16 Fr | In distribution |
| 509001 | Catheter Gauge 14 Fr | In distribution |
| 508991 | Length 8 in | In distribution |
| 508990 | Catheter Gauge 12 Fr | In distribution |
| 508998 | Catheter Gauge 18 Fr | In distribution |
| 509002 | Catheter Gauge 16 Fr | In distribution |
| 508989 | Length 8 in | In distribution |
| 508988 | Catheter Gauge 8 Fr | In distribution |
| 508993 | Length 16 in | In distribution |
| 509003 | Catheter Gauge 18 Fr | In distribution |
| 508999 | Catheter Gauge 10 Fr | In distribution |
| 508994 | Catheter Gauge 10 Fr | In distribution |
| 508997 | Catheter Gauge 16 Fr | In distribution |
| 508995 | Length 16 in | In distribution |
| 508996 | 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 |
| 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 |
|---|---|
| K261658 | 2026-07-17 |
| K260999 | 2026-04-24 |
| K250659 | 2025-09-26 |
| K123751 | 2013-02-28 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 2020-06-17 | Class II | Equipment maintenance | Wellspect Healthcare is voluntarily recalling certain LoFric Origo” urethral catheters due to a potential defect which may be present in the catheter s distal tip. | 2021-04-09 |
| 2020-06-17 | Class II | Equipment maintenance | Wellspect Healthcare is voluntarily recalling certain LoFric Origo” urethral catheters due to a potential defect which may be present in the catheters distal tip. | 2021-04-09 |
| 2020-06-17 | Class II | Equipment maintenance | Wellspect Healthcare is voluntarily recalling certain LoFric Origo” urethral catheters due to a potential defect which may be present in the catheters distal tip. | 2021-04-09 |
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.