Data / Medical devices / China / Guangzhou PINZHI Medical Device Co., Ltd.
Guangzhou PINZHI Medical Device Co., Ltd.: FDA-registered device maker in Guangzhou Guangdong, China, 1 510(k) clearance
Guangzhou PINZHI Medical Device Co., Ltd. is registered with the FDA (registration 3033740404) in Guangzhou Guangdong, China. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 3, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3033740404
- Address
- Room 405, 4th Floor, No.600-2 Guangshan 2nd Road, Fenghuang Street, Tianhe District, Guangzhou Guangdong, China, 510520
- Owner or operator
- Guangzhou PINZHI Medical Device Co., Ltd. (10091393)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- October 14, 2024
- Registered through
- 2026
- Brand names listed
- 35mm culture dish, 60mm culture dish, 100mm culture dish, ICSI dish, Center well dish, 4 well dish, Sperm CD, Cryosonic Vault Automated Liquid Nitrogen Storage System, Denudation Pipettes, Denuding pipettes, ICSI pipettes, Holding pipettes, Biopsy pipettes, Holding pipettes for PGT, SFG Micropipettor, Sperm Collection Container
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Cryopreservation Storage System | QUJ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Labware, Assisted Reproduction, Exempt | PUD | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Micromanipulators And Microinjectors, Assisted Reproduction | MQJ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes) | MQH | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | 2 | Exporter to the US, 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 3, 2025 | K250838 | Denudation Pipettes | MQH | Substantially Equivalent | Guangzhou Pinzhi Medical Device Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Microtools, Assisted Reproduction (Pipettes)
- All makers of Automated Cryopreservation Storage System
- All makers of Microtools, Assisted Reproduction (Pipettes), Exempt
- All makers of Micromanipulators And Microinjectors, Assisted Reproduction
- All makers of Labware, Assisted Reproduction, Exempt
Updated July 3, 2025. 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.