Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023235140

FEI Number

3023235140

Entity Name

WUHAN HUCHUANG UNION TECHNOLOGY CO., LTD.

City/State/Country

Wuhan Hubei, CN

Establishment Address

Building10, No.818 Gaoxin Avenue, Wuhan Hubei 430206, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Wuhan Huchuang Union Technology Co., Ltd. (Owner Number: 10084962)

Owner / Operator Contact Address

Building10, No.818 Gaoxin Avenue, Wuhan, CN-HB 430206, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Assisted Reproduction Micropipettes, Pasteur Pipettes Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) Micromanipulation System IVF Certified Dish, Specimen Containers, Test Tube, Conical Tube, Warming Equipment

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	2022-04-20
MTX	Microscope And Microscope Accessories, Reproduction, Assisted	Obstetrics/Gynecology	Class 1	884.6190	2024-05-13
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2024-05-13
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2024-05-13
MQJ	Micromanipulators And Microinjectors, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6150	2022-12-05
PUD	Labware, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6160	2022-04-20

Official Correspondent

Yuanyuan Zhan

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Wuhan Huchuang Union Technology Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2020	CooperSurgical, Inc.	2	Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.

Similar Registrations

Registration Number	Establishment Name	Location
3033740404	Guangzhou PINZHI Medical Device Co., Ltd.	Guangzhou Guangdong, CN
3040387472	UKS Medical Technology (Chongqing) Co., Ltd.	Chongqing, CN
3010187826	GUANGZHOU HUADA BIOTECHNOLOGY CO., LTD.	Guangzhou Guangdong, CN
1319660	ISOMEDIX OPERATIONS INC.	CHESTER, NY, US
1220477	ISOMEDIX OPERATIONS INC.	Northborough, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023235140. Last updated year: 2026. Please use registration number 3023235140 when referencing this establishment in official correspondence.