Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3033813683

FEI Number

3033813683

Entity Name

SHANDONG WEGO RUISHENG MEDICAL DEVICE CO.,LTD

City/State/Country

Weihai Shandong, CN

Establishment Address

No.1, Weigao Road, Torch High-tech Industrial Development Zone,, Weihai Shandong 264210, CN

Establishment Type(s)

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

Owner / Operator

Shandong Wego Ruisheng Medical Device Co.,Ltd (Owner Number: 10091582)

Owner / Operator Contact Address

No.1, Weigao Road, Torch High-tech Industrial Development Zone,, Weihai, CN-SD 264210, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233477

PMA Number

N/A

All Registered Proprietary Names

Cryo-straw (Type I, Type III); Warming Kit (A-4ML, B-8ML); Vitrification Kit (A-3ML, B-6ML)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2024-10-17
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2024-10-17

Official Correspondent

Tian Yan

US Agent Details

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

Related Public Records

Same Entity

Shandong Wego Ruisheng Medical Device 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033813683. Last updated year: 2026. Please use registration number 3033813683 when referencing this establishment in official correspondence.