FDA Registration
Active
🇨🇳 China
JIANGSU CHANGMEI MEDTECH CO.,LTD
Reg #: 3016789487
·
FEI: 3016789487
·
Expires 2026
Products
8
Proprietary Names
5
Establishment Types
3
Classifications
8
Registration Details
- Registration Name
- JIANGSU CHANGMEI MEDTECH CO.,LTD
- Registration Number
- 3016789487
- FEI Number
- 3016789487
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.27, Xinke West Road, Luoyang Town, Wujin District
- City
- Changzhou Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K223709
Owner / Operator
- Firm Name
- Jiangsu Changmei Medtech Co.,Ltd
- Operator Number
- 10065161
- Address
- No.27, Xinke West Road, Luoyang Town, Wujin District
- City
- Changzhou
- State
- Jiangsu
- Postal Code
- 213104
- Country
- CN
- Correspondent
- Yufang Shen
US Agent
- Business Name
- MEDRIGHT TECH INC
- Contact Name
- Jessie Yao
- Address
- 6302 FORT HAMILTON PARKWAY, 1R
- City
- Brooklyn
- State
- NY
- ZIP
- 11219
- Country
- US
- [email protected]
- Phone
- 718 2169957
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Spinal Channeling Instrument, Vertebroplasty | OCJ | Class 1 | Orthopedic | No | 2024-02-21 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2024-07-17 |
| Dilator, Esophageal | KNQ | Class 2 | Gastroenterology, Urology | No | 2024-07-18 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2023-08-17 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2023-08-17 |
| Injector, Vertebroplasty (Does Not Contain Cement) | OAR | Class 1 | Orthopedic | No | 2024-02-21 |
| Dispenser, Cement | KIH | Class 1 | Orthopedic | No | 2024-02-21 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2024-02-21 |
Proprietary Names
Kyphoplasty Tool Kit
Disposable Endoscopic Hose-type Biopsy Forceps
Dilation Balloon Catheter
Kyphoplasty Balloon Catheter
Balloon Inflator
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198