Data / Medical devices / China / Suzhou Leapmed Healthcare Corporation
Suzhou Leapmed Healthcare Corporation: FDA-registered device maker in suzhou Jiangsu, China, 5 510(k) clearances
Suzhou Leapmed Healthcare Corporation is registered with the FDA (registration 3013462478) in suzhou Jiangsu, China. It lists 3 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 6, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013462478
- Address
- Building 7, No. 188 Fuchunjiang Road, SND, suzhou Jiangsu, China, 215163
- Owner or operator
- Suzhou Leapmed Healthcare Corporation (10061699)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 11, 2019
- Registered through
- 2027
- Brand names listed
- 10200303 10206203 10206203 10207403 10207403 10206103 10206103 10202703 10202703, 10200503 10200503 10205803 10205803 10200903 10200903 10201703 10201703 10208203, 10200603 10204103 10204103 10203603 10203603 10203403 10203403 10211803 10211803, 10201103 10201803 10201803 10200403 10200403 10201203 10201203 10205303 10205303, 10201803 10201003 10201003 10202503 10202503 10204503 10204503 10211503 10211503, 10202003 10202003 10203003 10203003 10202803 10202803 10202303 10203303 10203303, 10202103 10202103 10205703 10205703 10212003 10212003 10207003 10207003, 10202203 10202203 10202103 10202103 10204803 10204803 10207003 10207003 10212203 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Biopsy Needle | FCG | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Biopsy | KNW | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 6, 2022 | K212822 | Disposable Coaxial Biopsy Needle | FCG | Substantially Equivalent | Suzhou Leapmed Healthcare Corporation | accessdata.fda.gov |
| July 6, 2022 | K212820 | Disposable Semi Automatic Biopsy Instrument | KNW | Substantially Equivalent | Suzhou Leapmed Healthcare Corporation | accessdata.fda.gov |
| July 6, 2022 | K212819 | Disposable Biopsy Refill Needle | FCG | Substantially Equivalent | Suzhou Leapmed Healthcare Corporation | accessdata.fda.gov |
| November 10, 2021 | K212284 | Disposable Automatic Core Biopsy Instrument | KNW | Substantially Equivalent | Suzhou Leapmed Healthcare Corporation | accessdata.fda.gov |
| October 30, 2001 | K011265 | ULTRASOUND TRANSDUCER COVER | ITX | Substantially Equivalent | Advance Medical Designs, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Instrument, Biopsy
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Biopsy Needle
Updated July 6, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.