Suzhou Leapmed Healthcare Corporation
Manufacturer and brand owner in Suzhou, Jiangsu, China. 3 device types, 2 products catalogued, 4 clearances.
Suzhou Leapmed Healthcare Corporation is a contract manufacturer holding a current FDA establishment registration. The registration covers Biopsy Needle, Instrument, Biopsy and 1 other device type. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | SUZHOU LEAPMED HEALTHCARE CORPORATION |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013462478 |
| FEI number | 3013462478 |
| DUNS | 544411637 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 苏州市立普医疗科技有限公司 |
|---|---|
| Unified social credit code | 91320506573831362T |
| Source | NMPA UDI database |
Location
| City | Suzhou |
|---|---|
| Province | Jiangsu |
| Address | Building 7, No. 188 Fuchunjiang Road, SND |
| Postal code | 215163 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Biopsy Needle | Class 2 | Disposable Coaxial Biopsy Needle, Disposable Biopsy Refill Needle | 2022 | 3 |
| Instrument, Biopsy | Class 2 | Disposable Semi Automatic Biopsy Instrument, Disposable Automatic Core Biopsy Instrument | 2022 | 9 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | GG514 GG515 GG516 GG517 GG518 GG519 GG520 GG521 GG522 GG523 GG524 GG525 GG526, EG100 EG101 EG104 EG105 EG106 EG107 EG110 EG111 EG118 EG119 EG120 EG121 EG122, GG540 GG541 GG542 GG543 GG546 GG547 GG548 GG549 GG550 GG551 GG552 GG553 GG554, 10203803 10203803 10202103 10202103 10204203 10204203 10204303 10204303 10201103, GG555 GG556 GG557 GG558 GG559 GG560 GG561 GG562 GG563 GG566 GG567 GG568 GG569, EG155 EG156 EG157 EG158 EG159 EG160 EG161 EG174 EG175 EG176 EG177 EG178 EG179 EG188 and 46 more | 2019 | 44 |
Own-Brand Listings
Clearances
4 clearances name Suzhou Leapmed Healthcare Corporation as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K212819 | 2022-07-06 | FCG | Traditional | This company |
| K212820 | 2022-07-06 | KNW | Traditional | This company |
| K212822 | 2022-07-06 | FCG | Traditional | This company |
| K212284 | 2021-11-10 | KNW | Traditional | This company |
| K011265 | 2001-10-30 | ITX | Traditional | Advance Medical Designs, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Main products | Ultrasound needle guides, Biopsy instruments, Puncture needles, Ultrasound gels, Probe covers |
| Certifications | ISO9001 |
| Export markets | Worldwide |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.