Data / Medical devices / China / Jiangxi Zhuoruihua Medical Instrument Co., Ltd.
Jiangxi Zhuoruihua Medical Instrument Co., Ltd.: FDA-registered device maker in Ji 'an Jiangxi, China, 1 510(k) clearance
Jiangxi Zhuoruihua Medical Instrument Co., Ltd. is registered with the FDA (registration 3016696686) in Ji 'an Jiangxi, China. It lists 8 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 2, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3016696686
- Address
- 14th Industrial Building, Xiajiang Industrial Zone, Xiajiang, Ji 'an Jiangxi, China, 331409
- Owner or operator
- Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd. (10086114)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 17, 2022
- Registered through
- 2026
- Brand names listed
- Bite Block, Disposable Cleaning Brush, Disposable Cytology Brush, Disposable Endoscopy Valve Sets, Disposable Grasping Forceps, Disposable Stone Retrieval Basket, Disposable biopsy forceps, Haemostasis clip and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Manufacturer | accessdata.fda.gov |
| Bottle, Collection, Vacuum | KDQ | 2 | Manufacturer | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Manufacturer | accessdata.fda.gov |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | 2 | Manufacturer | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Manufacturer | accessdata.fda.gov |
| Forceps, Biopsy, Non-Electric | FCL | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Hemostatic Metal Clip For The Gi Tract | PKL | 2 | Manufacturer | accessdata.fda.gov |
| Valve, Switching (Ploss) | JFE | 1 | 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 |
|---|---|---|---|---|---|---|
| January 2, 2025 | K241005 | Haemostasis Clips | PKL | Substantially Equivalent | Jiangxi Zhuoruihua Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Bottle, Collection, Vacuum
- All makers of Accessories, Cleaning Brushes, For Endoscope
- All makers of Valve, Switching (Ploss)
- All makers of Clamp, Surgical, General & Plastic Surgery
- All makers of Forceps, Biopsy, Non-Electric
- All makers of Dislodger, Stone, Basket, Ureteral, Metal
Updated January 2, 2025. 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.