Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030681110

FEI Number

3030681110

Entity Name

GIMBO MEDICAL TECHNOLOGY SHENZHEN CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

601, Building C5, No. 459 Qiaokai Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Provinc, Shenzhen Guangdong 518107, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Gimbo Medical Technology Shenzhen Co., Ltd. (Owner Number: 10088612)

Owner / Operator Contact Address

601, Building C5, No. 459 Qiaokai Road, Fenghuang Street, Guangming District, Shenzhen City, Guangdong Provinc, Shenzhen, CN-GD 518107, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242043

PMA Number

N/A

All Registered Proprietary Names

Giftlife Single Step Medium Giftlife Fertilization Medium Giftlife Blastocyst Medium Giftlife Cleavage Medium Giftlife® Single-Step Medium Plus G-vitri Vitrification media; G-vitri Warming media G-Vitri Vitrification Straw Oocyte Flushing & Retrieval Medium; Gamete Buffer Sperm Freezing Medium

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2024-06-17
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2024-12-02
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2024-02-29
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2024-06-17
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2024-05-15
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2025-01-14

Official Correspondent

Yifan Zhao

US Agent Details

Ronald Rakos Business: MedTech + Regulatory Consultants, LLC. Email: rrakos@medtechrac.com Phone: (908) 8723280

Related Public Records

Same Entity

Gimbo Medical Technology Shenzhen Co., Ltd.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K011481	Conception Technologies	10% PVP; 10% PVP IN EBSS SOLUTION	2001-07-02

Similar Registrations

Registration Number	Establishment Name	Location
2031824	Vitrolife Inc.	San Diego, CA, US
3014295858	COOPER MEDICAL, SRL	La Garita Alajuela, CR
3014755376	CooperSurgical Distribution B.V.	Herten Limburg, NL
3036725842	GYNOTEC B.V.	Malden Gelderland, NL
3004048494	ORIGIO A/S	Ballerup Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030681110. Last updated year: 2026. Please use registration number 3030681110 when referencing this establishment in official correspondence.