Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018779125

FEI Number

3018779125

Entity Name

CHANGSHA RENJI MEDICAL EQUIPMENT CO., LTD.

City/State/Country

Changsha Hunan, CN

Establishment Address

201, Stage 4, Changsha E Center, No.18 Xiangtai Road, Liuyang Jingkai District, Changsha Hunan 410329, CN

Establishment Type(s)

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

Owner / Operator

Changsha Renji Medical Equipment Co., Ltd. (Owner Number: 10081079)

Owner / Operator Contact Address

201, Stage 4, Changsha E Center, No. 18 Xiangtai Road, Liuyang Jingkai District, Changsha, CN-HN 410329, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Transfer Pipette Serological Pipette Viral RNA&DNA Extraction Kit; Sample Release Kit Disposable Urine Container Disposable Stool Container Saliva Collection Kit Biosafety Bag Disposable Urine Tube Sample Container Viral Transport Medium(VTM) Swab Kits Disposable Virus Specimen Collection Tube Disposable Automatic Venous Compression Band Blood Collection Tube Pipette Tip Disposable Virus Specimen Collection Tube Viral Transport Medium(VTM) Swab Kits Saline Transport Medium Disposable Vaginal Speculum Disposable Sampling Swab Specimen Collection Flocked Swabs Petri Dish

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GJW	Pipette, Pasteur	Hematology	Class 1	864.6160	2023-04-19
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2023-04-19
NNI	Container, Specimen, Non-Sterile	Pathology	Class 1	864.3250	2023-04-19
JSM	Culture Media, Non-Propagating Transport	Microbiology	Class 1	866.2390	2021-03-16
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2023-03-21
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2023-04-19
JRC	Micro Pipette	Clinical Chemistry	Class 1	862.2050	2023-03-21
QMC	Transport Medium, Notified Per The Vtm Guidance	Microbiology	Class 1	866.2390	2021-03-16
HIB	Speculum, Vaginal, Nonmetal	Obstetrics/Gynecology	Class 2	884.4530	2023-03-21
KXG	Applicator, Absorbent Tipped, Sterile	General Hospital	Class 1	880.6025	2021-03-16
KIZ	Dish, Tissue Culture	Hematology	Class 1	864.2240	2023-03-21

Official Correspondent

Yong Zhu

US Agent Details

Wei ZHANG Business: 3dstocking Inc Email: ge@3dstocking.com Phone: (772) 9996108

Related Public Records

Same Entity

Changsha Renji Medical Equipment 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
K914894	Microtest	VIRAPURE, CHLAMYPURE AND MYCOPURE	1991-12-18

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018779125. Last updated year: 2026. Please use registration number 3018779125 when referencing this establishment in official correspondence.