Innovex Medical Co., Ltd.
Registered establishment in Shanghai, China. 5 device types.
Innovex Medical Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Stylet, Ureteral, Bottle, Collection, Vacuum and 3 other device types. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | INNOVEX MEDICAL CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3032859397 |
| FEI number | 3032859397 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Shanghai |
|---|---|
| Province | Shanghai |
| Address | 2nd Floor, No.17 Building, 315 Qingda Rd, Pudong, 201201 Shanghai, P.R. China |
| Postal code | 201201 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bottle, Collection, Vacuum | Class 2 | Urological Sampler Sets (IVX-NB-150) | 2024 | 88 |
| Dislodger, Stone, Flexible | Class 2 | Urological Stone Extraction Baskets(IVX-US-T0810, IVX-US-T0810S, IVX-US-T1110, IVX-US-T1110S), Urological Stone Extraction Baskets(IVX-US-F1110, IVX-US-F1110S, IVX-US-F1110L); | 2025 | 2 |
| Endoscopic Access Overtube, Gastroenterology-Urology | Class 2 | Hoover Negative Pressure Access Sheath(IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250) | 2025 | 19 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Class 2 | Single Use Grasping Forceps(IVX-GF1-1806A, IVX-GF1-1808A, IVX-GF1-1810A, IVX-GF1-1812A) | 2025 | 21 |
| Stylet, Ureteral | Class 1 | OBSIDIAN(OBSI3515S and OBSI3815S) | 2026 | 2 |
Clearances
No clearance names Innovex Medical Co., Ltd. as applicant. One is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K243820 | 2025-01-31 | FED | Traditional | Dornier Medtech America, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2009 |
|---|---|
| Employees | 500-1000 |
| Main products | Single use flexible ureterorenoscope, Single use flexible cystoscope, Ureteral access sheath, Urological stone extraction baskets, Single use flexible choledochoscope |
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.