Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017305295

FEI Number

3017305295

Entity Name

TCI GENE INC.

City/State/Country

Taipei, TW

Establishment Address

10F-1, No. 185, Kang Chien Road, Nei Hu District, Taipei 11494, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TCI GENE INC. (Owner Number: 10075290)

Owner / Operator Contact Address

10F-1, No. 185, Kang Chien Road, Nei Hu District, Taipei, TW-NOTA 11494, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TCI QVS-96S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JTC	Device, Microtiter Diluting/Dispensing	Microbiology	Class 1	866.2500	2020-06-11

Official Correspondent

Chelsea Chen

US Agent Details

Travis Hsu Business: Qualtech Consulting LLC Email: travis@qualtechs.com Phone: (626) 3455899

Related Public Records

Same Entity

TCI GENE INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
1119779	BECTON, DICKINSON & CO.	SPARKS, MD, US
3009974297	Plastikon Industries	Hayward, CA, US
3003750284	REMEL EUROPE LTD	DARTFORD, KENT, GB
3014397113	MBD CO., LTD.	Suwon-si Gyeonggi, KR
3009963993	AZER SCIENTIFIC, INC.	Morgantown, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017305295. Last updated year: 2026. Please use registration number 3017305295 when referencing this establishment in official correspondence.