Facility

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

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

Key facts

1recalls · worst Class I

1inspections · worst NAI

—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)	3018312328
Establishment type	Manufacture Medical Device
Location	Building 5 No. 21 Courtyard, Panlong West Road Beijing, CN 10120
Registration status	Active · expires 2026
Parent company	Lepu Medical Technology (Beijing) Co., Ltd (owner-operator 10038811)
Brand names	Vasc Band

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Clamp, Vascular
Product code DXC (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.4450

Recalls & enforcement

Class ICompleted2021-04-26
Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography) is not authorized, cleared, or approved for marketing and/or distribution in the U.S.

FDA inspections (1)

NAI2026-03-06
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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. “LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD (FEI 3018312328) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3018312328-lepu-medical-technology-beijing-co-ltd/

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