Well Lead Medical (Hainan) Co., Ltd.
Registered establishment in Haikou, Hainan, China. 3 device types, 1 clearance.
Well Lead Medical (Hainan) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Catheter, Retention Type, Balloon, Catheter, Ureteral, Gastro-Urology and 1 other device type. Its earliest product listing with the FDA dates from 2023.
3device types registered with the FDA
1510(k) clearance
Registration
| Registered name | WELL LEAD MEDICAL (HAINAN) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3027301746 |
| FEI number | 3027301746 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Haikou |
|---|---|
| Province | Hainan |
| Address | No. 39, Mei’an 3rd Street, Mei’an Ecological Science Park, 571157 ,Haikou, Hainan, China |
| Postal code | 570000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheter, Retention Type, Balloon | Class 2 | Latex Foley Catheter, Wellead Latex Foley Catheter, AMSure Silicone Coated Latex Foley Catheter | 2023 | 17 |
| Catheter, Ureteral, Gastro-Urology | Class 2 | AMSure Red Rubber Urethral Catheter, Wellead Latex Foley Catheter | 2023 | 4 |
| Catheter, Urological (Antimicrobial) And Accessories | Class 2 | Wellead Latex Foley Catheter | 2024 | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233094 | 2024-06-06 | MJC | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Employees | 1001-5000 |
| Main products | Foley catheters, Urine bags, Hydrophilic intermittent catheters, Surgical instruments, Anesthesia products |
| Export markets | 100+ countries |
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.