FDA Registration
Active
🇨🇳 China
JIANGXI ZHUORUIHUA MEDICAL INSTRUMENT CO., LTD.
Reg #: 3016696686
·
FEI: 3016696686
·
Expires 2026
Products
8
Proprietary Names
9
Establishment Types
2
Classifications
8
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Registration Details
- Registration Name
- JIANGXI ZHUORUIHUA MEDICAL INSTRUMENT CO., LTD.
- Registration Number
- 3016696686
- FEI Number
- 3016696686
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 14th Industrial Building, Xiajiang Industrial Zone, Xiajiang
- City
- Ji 'an Jiangxi
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K241005
Owner / Operator
- Firm Name
- Jiangxi ZhuoRuiHua Medical Instrument Co., Ltd.
- Operator Number
- 10086114
- Address
- 14th Industrial Building, Xiajiang Industrial Zone, Xiajiang
- City
- Ji 'an
- State
- Jiangxi
- Postal Code
- 331409
- Country
- CN
- Correspondent
- Yangfang Liu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2024-06-06 |
| Valve, Switching (Ploss) | JFE | Class 1 | Anesthesiology | No | 2025-12-11 |
| Endoscopic Bite Block | MNK | Class 1 | Gastroenterology, Urology | No | 2024-06-06 |
| Hemostatic Metal Clip For The Gi Tract | PKL | Class 2 | Gastroenterology, Urology | No | 2025-02-05 |
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2024-06-06 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2022-10-17 |
| Accessories, Cleaning Brushes, For Endoscope | MNL | Class 1 | Gastroenterology, Urology | No | 2024-06-06 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2024-06-06 |
Proprietary Names
Disposable Stone Retrieval Basket
Disposable Endoscopy Valve Sets
Bite Block
Haemostasis clip
Multi-chamber polyp Trap
Disposable biopsy forceps
Disposable Cytology Brush
Disposable Cleaning Brush
Disposable Grasping Forceps
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device