Data / Medical devices / China / Jiangsu JianYu Health Medical Co., Ltd
Jiangsu JianYu Health Medical Co., Ltd: FDA-registered device maker in Changzhou City Jiangsu, China, 1 510(k) clearance
Jiangsu JianYu Health Medical Co., Ltd is registered with the FDA (registration 3014926389) in Changzhou City Jiangsu, China. It lists 37 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 30, 2020. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3014926389
- Address
- No. 88 Longxi Avenue, Zhulin Town Jintan District, Changzhou City Jiangsu, China, 213241
- Owner or operator
- Jiangsu JianYu Health Medical Co., Ltd (10039161)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- December 14, 2011
- Registered through
- 2027
- Brand names listed
- Amniotic Membrane Perforator, Brush, Scrub, Operating-Rooms, Burn Sheet, Clamp, umbilical, Drain Glider, Drape Surgical, FLUID FIGHTER SUCTION MAT;SUCTION MAT;SUCTION RING; SUCTION RING WITH TUBING;, Gauze / sponge, internal, X-ray detectable and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Amniotome | HGE | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 | Contract manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Basic Set-Up Tray | PXN | 1 | Contract manufacturer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Brush, Scrub, Operating-Room | GEC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Contract manufacturer | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Clamp, Umbilical | HFW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Container, Specimen, Non-Sterile | NNI | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Counter, Sponge, Surgical | LWH | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cup, Prophylaxis | EHK | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Dental Hygiene Kit | NXZ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Device, Occlusion, Umbilical | FOD | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Device, Paste-On For Incontinence, Non-Sterile | NOA | 1 | Contract manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Contract manufacturer | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Contract manufacturer | accessdata.fda.gov |
| Fiber, Medical, Absorbent | FRL | 1 | Manufacturer | accessdata.fda.gov |
| Fluid Drainage Tray | PXU | 1 | Contract manufacturer | accessdata.fda.gov |
| Gastrointestinal Tubes With Enteral Specific Connectors | PIF | 2 | Contract manufacturer | accessdata.fda.gov |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | 1 | Contract manufacturer | accessdata.fda.gov |
| Gown, Surgical | FYA | 2 | Contract manufacturer | accessdata.fda.gov |
| Holder, Ureteral Catheter | EYJ | 1 | Contract manufacturer | accessdata.fda.gov |
| Hook, Gastro-Urology | FHB | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Specialized Obstetric-Gynecologic | KNA | 2 | Manufacturer | accessdata.fda.gov |
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Suturing, Disposable | GAB | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Pump, Air, Non-Manual, For Endoscope | FEQ | 2 | Contract manufacturer | accessdata.fda.gov |
| Restraint, Protective | FMQ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Scissors, Umbilical | HDJ | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Sheet, Burn | FPY | 1 | Contract manufacturer | accessdata.fda.gov |
| Suit, Surgical | FXO | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| December 30, 2020 | K201754 | JianYu Surgical Mask | FXX | Substantially Equivalent | Jiangsu Jianyu Health Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Fiber, Medical, Absorbent
- All makers of Cup, Prophylaxis
- All makers of Device, Occlusion, Umbilical
- All makers of Mask, Surgical
- All makers of Clamp, Surgical, General & Plastic Surgery
- All makers of Counter, Sponge, Surgical
Updated December 30, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.