Jiangsu JianYu Health Medical Co., Ltd.
Registered establishment in Changzhou, Jiangsu, China. 35 device types, 1 clearance.
Jiangsu JianYu Health Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Amniotome, Sheet, Burn and 33 other device types. Its earliest product listing with the FDA dates from 2011.
35device types registered with the FDA
1510(k) clearance
Registration
| Registered name | Jiangsu JianYu Health Medical Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014926389 |
| FEI number | 3014926389 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 江苏健裕健康医疗器械有限公司 |
|---|---|
| Unified social credit code | 913204137812663534 |
| Source | NMPA UDI database |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No. 88 Longxi Avenue, Zhulin Town |
| Postal code | 213241 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Amniotome | Class 1 | Hook,amnio,plastic,sterile | 2022 | 5 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | Class 2 | Fluid Fighter Suction Mat;suction Mat;suction Ring; Suction Ring With Tubing; | 2019 | 30 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | Drain Glider | 2026 | 58 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Oral Care Spongestick,dentips,treated or untreated | 2015 | 186 |
| Applicator, Resin | Class 1 | Resin Applicator | 2011 | 24 |
| Bottle, Collection, Vacuum | Class 2 | TrapEase Poly Trap, TrapEase Stone Trap | 2014 | 88 |
| Brush, Scrub, Operating-Room | Class 1 | Brush, Scrub, Operating-Rooms | 2013 | 42 |
| Catheter And Tip, Suction | Class 2 | Yankauer; Suction Swab; Suction Toothbrush;Suction Handle ;Y-Connector;Suction Catheter;Nasal Aspirator | 2019 | 70 |
| Clamp, Surgical, General & Plastic Surgery | Class 1 | 2013 | 16 | |
| Clamp, Umbilical | Class 2 | Clamp, umbilical | 2017 | 14 |
| Container, Specimen, Non-Sterile | Class 1 | 2016 | 115 | |
| Container, Specimen, Sterile | Class 1 | 2016 | 79 | |
| Counter, Sponge, Surgical | Class 1 | Surgical, Sponge Stick and others | 2013 | 17 |
| Cup, Prophylaxis | Class 1 | Prophylaxis Cup | 2011 | 49 |
| Dental Hygiene Kit | Class 1 | Oral Care Kits | 2024 | 12 |
| Device, Occlusion, Umbilical | Class 1 | Sterile Umbilical cord clamp | 2018 | 18 |
| Device, Paste-On For Incontinence, Non-Sterile | Class 1 | TotalFit External catheter; TotalFit External catheter + TotalSecure Securement Device | 2025 | 13 |
| Drape, Surgical, Exempt | Class 2 | Drape Surgical | 2022 | 107 |
| Endoscopic Bite Block | Class 1 | 2014 | 44 | |
| Fiber, Medical, Absorbent | Class 1 | round fluff sponges, Medical Absorbent Fiber | 2012 | 172 |
| Gastrointestinal Tubes With Enteral Specific Connectors | Class 2 | Medline Enteral Feeding Sets | 2024 | 17 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Gauze / sponge, internal, X-ray detectable | 2012 | 67 |
| Gown, Surgical | Class 2 | Surgical Gowns | 2022 | 68 |
| Holder, Ureteral Catheter | Class 1 | TotalSecure Securement Device | 2025 | 29 |
| Hook, Gastro-Urology | Class 1 | Hook, Gastro-Urology | 2021 | 4 |
| Instrument, Manual, Specialized Obstetric-Gynecologic | Class 2 | Amniotic Membrane Perforator | 2017 | 1 |
| Mask, Surgical | Class 2 | Surgical Mask | 2021 | 125 |
| Needle, Suturing, Disposable | Class 1 | 2013 | 21 | |
| Pump, Air, Non-Manual, For Endoscope | Class 2 | 2018 | 4 | |
| Restraint, Protective | Class 1 | 2015 | 28 | |
| Scissors, Umbilical | Class 1 | Umbilical Cord Clamp Clipper Cutter | 2024 | 9 |
| Sheet, Burn | Class 1 | Burn Sheet | 2025 | 20 |
| Suit, Surgical | Class 1 | Surgical Suit | 2011 | 74 |
| Tray, Surgical, Instrument | Class 1 | 2014 | 105 | |
| Tubes, Gastrointestinal (And Accessories) | Class 2 | Medline Enteral Feeding Sets | 2024 | 25 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K201754 | 2020-12-30 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Factory area | 40000 m² |
| Main products | Medical dressings, Infection control products, Endoscope cleaning products, Laboratory products, PPE |
| Certifications | ISO9001, ISO13485, CE, FDA |
Nearby Manufacturers
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.
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