Facility

LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD

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

Key facts

1recalls · worst Class I

2inspections · worst VAI

1warning letters

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

FDA Establishment Identifier (FEI)	3008002401
Establishment type	Manufacture Medical Device
Location	No.37 Chaoqian Rd. Beijing, CN 10220
Registration status	Active · expires 2026
Parent company	Lepu Medical Technology (Beijing) Co., Ltd (owner-operator 10038811)
Brand names	Shoocin Introducer Kit

Activity by year

Recalls (1)
Inspections (2)
Warning letters (1)

Devices registered here (1)

Introducer, Catheter
Product code DYB (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1340

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 (2)

NAI2026-03-06
No Action Indicated · Compliance: Devices
VAI2023-11-23
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: 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.

FDA warning letters (1)

Warning Letter2021-07-29
Warning Letter (opens in a new tab) · Changping

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

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 3008002401) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008002401-lepu-medical-technology-beijing-co-ltd/

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