Well Lead Medical Co., Ltd.
Manufacturer and brand owner in Guangzhou, Guangdong, China. 46 device types, 48 products catalogued, 17 clearances.
Well Lead Medical Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Lavage, Jet, Mask, Oxygen and 44 other device types. 46 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2003.
Registration
| Registered name | WELL LEAD MEDICAL CO. LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010400865 |
| FEI number | 3010400865 |
| DUNS | 544811862 |
| Establishment type | Contract manufacturer, Contract steriliser, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 广州维力医疗器械股份有限公司 |
|---|---|
| Unified social credit code | 91440101759431420M |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | No. 47 Guomao Avenue South |
| Postal code | 511434 |
| Country | China |
What It Makes
Own-Brand Listings
Clearances
17 clearances name Well Lead Medical Co., Ltd. as applicant. 5 are 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 |
|---|---|---|---|---|
| K241734 | 2025-03-05 | GBM | Traditional | This company |
| K220722 | 2023-05-22 | EZD | Traditional | This company |
| K220036 | 2022-12-16 | KOD | Traditional | This company |
| K211543 | 2022-07-21 | BTR | Traditional | This company |
| K211814 | 2022-01-14 | ODC | Traditional | This company |
| K202134 | 2021-04-08 | EZL | Special | This company |
| K203119 | 2020-12-09 | FED | Special | This company |
| K182739 | 2019-12-11 | BTR | Special | This company |
| K162340 | 2017-10-11 | KNT | Traditional | This company |
| K160801 | 2016-11-29 | GCJ | Traditional | This company |
| K161110 | 2016-10-12 | FED | Traditional | This company |
| K151084 | 2016-01-07 | FED | Traditional | This company |
| K140667 | 2014-12-15 | EZL | Traditional | This company |
| K142563 | 2014-10-28 | EZD | Traditional | This company |
| K133615 | 2014-02-24 | EZD | Traditional | This company |
| K110269 | 2011-08-26 | BTR | Traditional | This company |
| K091516 | 2009-10-16 | EZL | Traditional | This company |
| K092886 | 2010-03-11 | CBI | Traditional | Well Lead Medical Instruments |
| K082815 | 2008-10-08 | EZL | Traditional | Well Lead Medical Instruments |
| K073383 | 2008-07-10 | BTR | Traditional | Well Lead Medical Instruments |
| K042683 | 2005-02-18 | BTR | Traditional | Well Lead Medical Instruments |
| K042684 | 2005-02-17 | BTO | Traditional | Well Lead Medical Instruments |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2026-07-31 | Not classified | Process control | The 6Fr suction catheter could not pass through the samples smoothly. | 27200 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2004 |
|---|---|
| Main products | Medical catheters, Anesthesia devices, Urology products, Respiratory devices, Hemodialysis equipment |
| Certifications | FDA, CE |
| Export markets | 90+ countries |
| OEM and ODM | Offered |
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.