Data / Medical devices / China / Pzmedical Technology Co., Ltd.
Pzmedical Technology Co., Ltd.: FDA-registered device maker in Putuo District Shanghai, China, 2 510(k) clearances
Pzmedical Technology Co., Ltd. is registered with the FDA (registration 3013688559) in Putuo District Shanghai, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated August 23, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3013688559
- Address
- 5F, Building 13 No. 2 Suide Road, Putuo District Shanghai, China, 200331
- Owner or operator
- PZMedical Technology Co., Ltd. (10055327)
- Roles
- Manufacturer
- First device listed
- July 7, 2017
- Registered through
- 2027
- Brand names listed
- 3025Z, 3025ZF, 3030Z, 3543Z, 3543ZF, 4343Z, 4343ZF, 4386Z and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | 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 |
|---|---|---|---|---|---|---|
| August 23, 2021 | K212105 | 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF | MQB | Substantially Equivalent | Pzmedical Technology Co., Ltd. | accessdata.fda.gov |
| July 7, 2017 | K170480 | Models 3543A, 4343A, 2929A and A843B | MQB | Substantially Equivalent | Shanghai PZ Medical Technolgoy Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 23, 2021. 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.