Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015198783

FEI Number

3015198783

Entity Name

ANKON MEDICAL TECHNOLOGIES (SHANGHAI) CO., LTD.

City/State/Country

Shanghai, CN

Establishment Address

F 3, No 2218 Jinsui Road, Shanghai 201206, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Ankon Medical Technologies (Shanghai) Co., Ltd. (Owner Number: 10062371)

Owner / Operator Contact Address

6010 W Spring Creek Parkway, Plano, TX 75024, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IntraMarX Radiopaque Markers AGIROMC1-1 IntraMarX 3D Radiopaque Markers NaviCam Tether NaviCam Stomach Capsule and NaviCam Tether

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2020-01-17
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2020-05-28
QKZ	Magnetically Maneuvered Capsule Endoscopy System	Gastroenterology, Urology	Class 2	876.1310	2022-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

Tim Thomas Business: ANX ROBOTICA CORP. Email: tim.thomas@anxrobotics.com Phone: (770) 4802911

Related Public Records

Same Entity

Ankon Medical Technologies (Shanghai) 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 3015198783. Last updated year: 2026. Please use registration number 3015198783 when referencing this establishment in official correspondence.