Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043105517

FEI Number

3043105517

Entity Name

RD BIOMED (CHANGSHA) LTD.

City/State/Country

Changsha Hunan, CN

Establishment Address

Room 02, Unit 501, Building D7, Jinrong Enterprise Park,, Wangcheng Economic and Technological Development District, Changsha City, China, Changsha Hunan 410000, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

RD Biomed (Changsha) Limited (Owner Number: 10094603)

Owner / Operator Contact Address

Room 02, Unit 501, Building D7, Jinrong Enterprise Park, Wangcheng Economic and Technological Development Dist, Changsha, CN-HN 410000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Pepfast lateral flow in vitro diagnostic medical device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JLL	Tubeless Analysis, Gastric Acidity	Clinical Chemistry	Class 1	862.1320	2025-12-10

Official Correspondent

Huibo Liu

US Agent Details

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

Related Public Records

Same Entity

RD Biomed (Changsha) Limited

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043105517. Last updated year: 2026. Please use registration number 3043105517 when referencing this establishment in official correspondence.