Jiangsu Changmei Medtech Co., Ltd.
Manufacturer and brand owner in Changzhou, Jiangsu, China. 8 device types, 3 products catalogued, 1 clearance.
Jiangsu Changmei Medtech Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Tamp, Arthroscope and 6 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
8device types registered with the FDA
3products catalogued under its own name
1510(k) clearance
Registration
| Registered name | JIANGSU CHANGMEI MEDTECH CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3016789487 |
| FEI number | 3016789487 |
| DUNS | 560432633 |
| Establishment type | Contract manufacturer, Complaint-file establishment, Manufacturer |
Chinese Registration
| Chinese legal name | 江苏常美医疗器械有限公司 |
|---|---|
| Unified social credit code | 91320412072779017U |
| Source | NMPA UDI database |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No.27, Xinke West Road, Luoyang Town, Wujin District |
| Postal code | 213104 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Arthroscope | Class 2 | Kyphoplasty Balloon Catheter | 2023 | 21 |
| Dilator, Esophageal | Class 2 | Dilation Balloon Catheter | 2024 | 9 |
| Dispenser, Cement | Class 1 | Kyphoplasty Tool Kit | 2024 | 3 |
| Forceps, Biopsy, Non-Electric | Class 1 | Disposable Endoscopic Hose-type Biopsy Forceps | 2024 | 44 |
| Injector, Vertebroplasty (Does Not Contain Cement) | Class 1 | Kyphoplasty Tool Kit | 2024 | 5 |
| Orthopedic Manual Surgical Instrument | Class 1 | Kyphoplasty Tool Kit | 2024 | 53 |
| Spinal Channeling Instrument, Vertebroplasty | Class 1 | Kyphoplasty Tool Kit | 2024 | 5 |
| Tamp | Class 1 | Kyphoplasty Balloon Catheter, Balloon Inflator | 2023 | 7 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Kyphoplasty Balloon Catheter | HRX | 3 |
| Kyphoplasty Tool Kit | OCJ | 2 |
| Balloon Inflator | HXG | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K223709 | 2023-08-16 | HRX | Traditional | This company |
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.
The manufacturer named here can complete this record.