FDA Registration
Active
🇨🇳 China
Guangzhou PINZHI Medical Device Co., Ltd.
Reg #: 3033740404
·
FEI: 3033740404
·
Expires 2026
Products
5
Proprietary Names
6
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- Guangzhou PINZHI Medical Device Co., Ltd.
- Registration Number
- 3033740404
- FEI Number
- 3033740404
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 405, 4th Floor, No.600-2 Guangshan 2nd Road, Fenghuang Street, Tianhe District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K250838
Owner / Operator
- Firm Name
- Guangzhou PINZHI Medical Device Co., Ltd.
- Operator Number
- 10091393
- Address
- Room 405, 4th Floor, No.600-2 Guangshan 2nd Road, Fenghuang Street, Tianhe District
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 510520
- Country
- CN
- Correspondent
- Hestia Xu
US Agent
- Business Name
- Dynasty Medical Consulting Inc.
- Contact Name
- Linda Chen
- Address
- 302 Round Lake Dr
- City
- Rosenberg
- State
- TX
- ZIP
- 77469
- Country
- US
- [email protected]
- Phone
- 832 3809688
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Microtools, Assisted Reproduction (Pipettes), Exempt | PUC | Class 2 | Obstetrics/Gynecology | No | 2024-10-14 |
| Labware, Assisted Reproduction, Exempt | PUD | Class 2 | Obstetrics/Gynecology | No | 2024-10-14 |
| Micromanipulators And Microinjectors, Assisted Reproduction | MQJ | Class 2 | Obstetrics/Gynecology | No | 2024-10-14 |
| Automated Cryopreservation Storage System | QUJ | Class 2 | Obstetrics/Gynecology | No | 2024-10-14 |
| Microtools, Assisted Reproduction (Pipettes) | MQH | Class 2 | Obstetrics/Gynecology | No | 2025-12-11 |
Proprietary Names
Denuding pipettes, ICSI pipettes, Holding pipettes, Biopsy pipettes, Holding pipettes for PGT
35mm culture dish, 60mm culture dish, 100mm culture dish, ICSI dish, Center well dish, 4 well dish, Sperm CD
Sperm Collection Container
SFG Micropipettor
Cryosonic Vault Automated Liquid Nitrogen Storage System
Denudation Pipettes
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device