Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020977243

FEI Number

3020977243

Entity Name

TOMOCROSS INTERNATIONAL CO., LTD

City/State/Country

Taichung City, TW

Establishment Address

5F-1, No. 39. Sec. 2, Xiangshun E. Road, Beitun District, Taichung City 40661, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Tomocross International Co., LTD (Owner Number: 10083477)

Owner / Operator Contact Address

5F-1, No. 39. Sec. 2, Xiangshun E. Road, Beitun District, Taichung City, TW-TXG 40661, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IQ Brace

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NOC	Splint, Extremity, Non-Inflatable, External, Non-Sterile	General, Plastic Surgery	Class 1	878.3910	2021-11-23

Official Correspondent

Isao Yeh

US Agent Details

Mark Cooper Business: DARCO International, Inc. Email: mcooper@darcointernational.com Phone: (304) 5224883

Related Public Records

Same Entity

Tomocross International 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 3020977243. Last updated year: 2026. Please use registration number 3020977243 when referencing this establishment in official correspondence.