Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015140190

FEI Number

3015140190

Entity Name

Shenzhen VitaVitro Biotech Co.,Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

R601, Building B, and 301, Area 02, Building A, Hai Ke Xing Tech Park, Baoshan Road No.16, Pingshan District, Shenzhen Guangdong 518118, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen VitaVitro Biotech Co.,Ltd. (Owner Number: 10059112)

Owner / Operator Contact Address

R601, Building B, Hai Ke Xing Tech Park, Pingshan District, Baoshan Road No.16, Shenzhen, CN-GD 518118, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VitaVitro® Sperm Gradient Medium VitaVitro® Sperm Washing Medium VitaVitro® Double Lumen Oocyte Retrieval Needle VitaVitro® Single Lumen Oocyte Retrieval Needle VitaVitro Embryo Transfer Catheter VitaVitro Warming Kit VitaVitro Vitrification Kit VitaVitro Straw Set VitaVitro 1-Step Culture Medium VitaVitro® Flushing Buffer Medium VitaVitro® Gamete Buffer Medium VitaVitro® Fertilization 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	2022-02-08
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	Obstetrics/Gynecology	Class 2	884.6130	2022-12-19
MQE	Needle, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6100	2024-12-03
PUD	Labware, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6160	2022-12-19
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2024-08-23
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2018-12-01
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2018-12-01
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2019-09-01
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-10-27
QKI	Media, Reproductive, Exempt	Obstetrics/Gynecology	Class 2	884.6180	2022-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Shenzhen VitaVitro Biotech 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
K082727	Vitrolife Sweden AB	FOLLICLE ASPIRATION SET, REDUCED SINGLE LUMEN	2009-02-06
K112396	Kitazato Medical Co., Ltd.	IUI CATHETERS	2012-11-02

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 3015140190. Last updated year: 2026. Please use registration number 3015140190 when referencing this establishment in official correspondence.