Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033740404

FEI Number

3033740404

Entity Name

Guangzhou PINZHI Medical Device Co., Ltd.

City/State/Country

Guangzhou Guangdong, CN

Establishment Address

Room 405, 4th Floor, No.600-2 Guangshan 2nd Road, Fenghuang Street, Tianhe District, Guangzhou Guangdong 510520, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device

Owner / Operator

Guangzhou PINZHI Medical Device Co., Ltd. (Owner Number: 10091393)

Owner / Operator Contact Address

Room 405, 4th Floor, No.600-2 Guangshan 2nd Road, Fenghuang Street, Tianhe District, Guangzhou, CN-GD 510520, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	Obstetrics/Gynecology	Class 2	884.6130	2024-10-14
PUD	Labware, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6160	2024-10-14
MQJ	Micromanipulators And Microinjectors, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6150	2024-10-14

Official Correspondent

Hestia Xu

US Agent Details

Linda Chen Business: Dynasty Medical Consulting Inc. Email: usagent@chonconn.com Phone: (832) 3809688

Related Public Records

Same Entity

Guangzhou PINZHI Medical Device Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033740404. Last updated year: 2026. Please use registration number 3033740404 when referencing this establishment in official correspondence.