Lepu Medical Technology (Beijing) Co., Ltd
Beijing, CN
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD appears in FDA device records in Beijing, CN. FDA records list 7 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 7 510(k) clearances for Lepu Medical Technology (Beijing) Co., Ltd between 2011 and 2018. The busiest year on record is 2014, with 2. The most recent is 2018, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K172331 | Type I, Type II, Type III, Type IV | DYB | Unknown | |
| K172099 | Shoocin Introducer Kit | DYB | Substantially Equivalent | |
| K141707 | ULTRASKIN HYDROPHILIC GUIDE WIRE | DQX | Substantially Equivalent | |
| K142359 | Vasc Band hemostat | DXC | Substantially Equivalent | |
| K123475 | SHOOCIN INTRODUCER KIT | DYB | Substantially Equivalent | |
| K123473 | HOPER PTCA BALLOON CATHETER | LOX | Substantially Equivalent | |
| K111837 | RADIAL ARTERY COMPRESSION TOURNIQUET | DXC | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008002401 | 3008002401 | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD | No.37 Chaoqian Rd., Beijing 102200 CN | 2026 | |
| 3018312328 | 3018312328 | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD | Building 5 No. 21 Courtyard, Panlong West Road, Beijing 101204 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1620-2021 | Leccurate SARS-CoV-2, Antigen Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for the qualitative detection of antigen SARS-CoV-2 in clinical samples (nasal swab). | Antigen Rapid Test Kit is not authorized, cleared, or approved for marketing and/or distribution in the U.S. | Class I | Completed | |
| Z-1619-2021 | Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and venipuncture whole blood for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. | 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. | Class I | Completed |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain