Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013756293

FEI Number

3013756293

Entity Name

IMMETECH INDUSTRIAL CO.,LTD

City/State/Country

Dongguan City Guangdong, CN

Establishment Address

1st-3rd Floor, Building2, No.93, Hongmei Section, Hongmei Town, Dongguan City Guangdong 523160, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

IMMETECH INDUSTRIAL CO.,LTD (Owner Number: 10092065)

Owner / Operator Contact Address

1st-3rd Floor, Building2, No.93,Hongmei Section,, Hongmei Town, Dongguan City, CN-GD 523160, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Quadsense System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ONN	Intraoperative Orthopedic Joint Assessment Aid	Neurology	Class 2	882.4560	2024-11-30

Official Correspondent

Alexandra Le Sueur

US Agent Details

Bill Starr Email: bill@starboardCFO.com Phone: (310) 7176953

Related Public Records

Same Entity

IMMETECH INDUSTRIAL 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 3013756293. Last updated year: 2026. Please use registration number 3013756293 when referencing this establishment in official correspondence.