FDA Import Refusal FR1-0019217-3/13/1 — Well Lead Medical Co., Ltd.

Well Lead Medical Co., Ltd. — FEI 3003903031

The FDA refused shipment FR1-0019217-3/13/1 from Well Lead Medical Co., Ltd. (China) on Aug 6, 2025. The refused product falls under Devices — CATHETER, RETENTION TYPE, BALLOON. Cited charge: 2780 This firm has 5 or more other import refusals on record.

Refusal Details

Date
Aug 6, 2025
Country
China
Product Category
Devices
Product Code
78EZL CATHETER, RETENTION TYPE, BALLOON
Charges
2780

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.