Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3026875454

FEI Number

3026875454

Entity Name

TAIHU HUAMEI MEDICAL EQUIPMENT CO.,LTD

City/State/Country

Anqing City Anhui, CN

Establishment Address

No. 93, Zhanghe Group, Xiaochi Village, Xiaochi Town, Taihu County, Anqing City Anhui 246440, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Taihu Huamei Medical Equipment Co.,Ltd (Owner Number: 10087508)

Owner / Operator Contact Address

No. 93, Zhanghe Group, Xiaochi Village, Xiaochi Town, Taihu County, Anqing City, CN-AH 246440, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Ophthalmoscope Tuning Fork Percussor Stethoscope Otoscope

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2024-10-18
GWX	Fork, Tuning	Neurology	Class 1	882.1525	2023-03-08
GWZ	Percussor	Neurology	Class 1	882.1700	2023-03-08
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2023-03-08
ERA	Otoscope	Ear, Nose, Throat	Class 1	874.4770	2023-03-08

Official Correspondent

Yingen Zhang

US Agent Details

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

Related Public Records

Same Entity

Taihu Huamei 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
K932506	Rudolf Riester GmbH & Co. KG	RI-SCOPE (S)	1993-10-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3026875454. Last updated year: 2026. Please use registration number 3026875454 when referencing this establishment in official correspondence.