Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3027978493

FEI Number

3027978493

Entity Name

SHANGRAO ZHUOFAN INTELLIGENT TECHNOLOGY CO., LTD

City/State/Country

Shangrao Jiangxi, CN

Establishment Address

No. 1, Factory Building 4-1, No. 26, Juyuan Road, Shangrao Economic and Technological Development Zone,, Shangrao Jiangxi 334100, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shangrao Zhuofan Intelligent Technology Co., LTD (Owner Number: 10088616)

Owner / Operator Contact Address

No. 1, Factory Building 4-1, No. 26, Juyuan Road, Shangrao Economic and Technological Development Zone,, Shangrao, CN-JX 334100, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ZF-M614, ZF-M615, ZF-M616, ZF-M617, ZF-M618, ZF-M802, ZF-M803, ZF-M805, ZF-M806, ZF-M807, ZF-M808, ZF-M809, ZF-M900, ZF-M905, ZF-M906, ZF-M907, ZF-M908, ZF-M909, hearing-aid:ZF-M601, ZF-M602, ZF-M603, ZF-M605, ZF-M606, ZF-M607, ZF-M608, ZF-M609, ZF-M610, ZF-M611, ZF-M612, ZF-M613,

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QUF	Hearing Aid, Air-Conduction, Over The Counter	Ear, Nose, Throat	Class 1	874.3300	2023-08-30

Official Correspondent

Hui Xiao

US Agent Details

Dan Yuan Email: service20210328@hotmail.com Phone: (805) 3513025

Related Public Records

Same Entity

Shangrao Zhuofan Intelligent Technology Co., LTD

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 3027978493. Last updated year: 2026. Please use registration number 3027978493 when referencing this establishment in official correspondence.