Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011522961

FEI Number

3011522961

Entity Name

ISEN TECH.&TRADING CO., LTD.

City/State/Country

Beijing, CN

Establishment Address

3 Gaoli Zhang Road, Room 302A, Floor 3, Building 11, Beijing 100095, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ISEN Tech.&Trading Co., Ltd. (Owner Number: 10054871)

Owner / Operator Contact Address

3 Gaoli Zhang Road, Room 302A, Floor 3, Building 11, Beijing, CN-BJ 100095, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IG Pro IG AirC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWN	Nystagmograph	Neurology	Class 2	882.1460	2017-05-07
KHH	Stimulator, Caloric-Air	Ear, Nose, Throat	Class 1	874.1800	2018-07-13

Official Correspondent

Zhiyong Liu

US Agent Details

Han Liu Business: Coland Medical Technologies, Inc. Email: sliu@colandmedical.com Phone: (954) 5919309

Related Public Records

Same Entity

ISEN Tech.&Trading 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
K010059	Western Systems Research, Inc.	ENGPLUS	2001-02-27

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011522961. Last updated year: 2026. Please use registration number 3011522961 when referencing this establishment in official correspondence.