Facility

WELL LEAD MEDICAL (HAINAN) CO., LTD.

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3027301746
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	No. 39, Mei'an 3rd Street, Mei'an Ecological Science Park, 571157 ,Haikou, Hainan, China Haikou Hainan, CN 57000
Registration status	Active · expires 2026
Parent company	Well Lead Medical (Hainan) Co., Ltd. (owner-operator 10087515)
Brand names	AMSure Red Rubber Urethral Catheter

Activity by year

Recalls (1)

Devices registered here (1)

Catheter, Ureteral, Gastro-Urology
Product code EYB (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5130

Recalls & enforcement

Class IIOngoing2026-07-31
The 6Fr suction catheter could not pass through the samples smoothly.

All facilities operated by Well Lead Medical (Hainan) Co., Ltd.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “WELL LEAD MEDICAL (HAINAN) CO., LTD. (FEI 3027301746) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3027301746-well-lead-medical-hainan-co-ltd/

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