Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017247483

FEI Number

3017247483

Entity Name

CGN GRAY (SHENZHEN) TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Section B,4th Building,No. 33 Zhenxing Road,Liyuhe Industrial Zone,Loucun Community,Gongming Office, Shenzhen Guangdong 518107, CN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

CGN Gray (Shenzhen) Technology Co., Ltd. (Owner Number: 10073525)

Owner / Operator Contact Address

Section B,4th Building,No. 33 Zhenxing Road,Liyuhe Industrial Zone,Loucun Community,Gongming Office, Shenzhen, CN-GD 518107, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sperm Collection Container Centrifuge Tube 15 ml; Centrifuge Tube 50 ml Labware, assisted reproduction, exempt SINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE Embryo Transfer Catheter (ETC) Assortment Accessory, assisted reproduction LABWARE, ASSISTED REPRODUCTION

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2022-04-19
PUD	Labware, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6160	2020-05-11
FMK	Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2024-02-23
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2026-02-09
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2022-04-19
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2022-04-19

Official Correspondent

Lu Chen

US Agent Details

James H. Liao Email: jamess@sino2us.com Phone: (310) 3758169

Related Public Records

Same Entity

CGN Gray (Shenzhen) Technology 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
K130132	Medipurpose Pte. , Ltd.	BABYLANCE HEEL INCISION DEVICE	2013-02-11
K112396	Kitazato Medical Co., Ltd.	IUI CATHETERS	2012-11-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0044-2008	Becton Dickinson & Company	2	Microtainer Safety Flow Lancets; Green Sterile, Use Once and Discard; 1.4 mm Blade Length; 1.0mm Blade Width; Becton Dickinson Vacutainer Systems; Becton Dickinson & Company; Franklin Lakes, NJ 07417
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017247483. Last updated year: 2026. Please use registration number 3017247483 when referencing this establishment in official correspondence.