Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014590707

FEI Number

3014590707

Entity Name

TAIWAN BIOMATERIAL Company, Ltd.

City/State/Country

Zhubei Hsinchu, TW

Establishment Address

1F, No. 188, Sec. 1, Shengyi Rd., Zhubei City, Hsinchu County, Zhubei Hsinchu 302058, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Taiwan Biomaterial Co., Ltd. (Owner Number: 10058651)

Owner / Operator Contact Address

1F, No. 188, Sec. 1, Shengyi Rd., Zhubei, TW-HSQ 302058, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TRUVIC Peripheral Canister Zoom Aspiration Tubing Zoom POD TRUVIC Tubeset Zoom Duoport Canister Zoom Canister TRUVIC Generator Zoom Pump ZOOM Aspiration Tubing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2019-02-22
NRY	Catheter, Thrombus Retriever	Cardiovascular	Class 2	870.1250	2019-05-23

Official Correspondent

Wen-Hsi Wang

US Agent Details

Brian Prom Business: Imperative Care, Inc. Email: bprom@imperativecare.com Phone: (408) 5027548

Related Public Records

Same Entity

Taiwan Biomaterial 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
K082762	Aardvark Medical	AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE	2008-11-12
K033736	Concentric Medical, Inc.	MERCI RETRIEVER, MODELS 90065, 90066	2004-08-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-05	Kinetic Concepts, Inc	2	V.A.C. X-Large Granufoam Dressing Part Numbers M6275065/5, V.A.C. ATS and V.A.C. Freedom and M6275043/5 V.A.C. Classic. Manufactured by Kinetic Concepts, Inc., San Antonio, Texas 78230

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3003542872	NPA de México S. de R.L. de C.V.	TIJUANA Baja California, MX
3006446479	SUNSET HEALTHCARE SOLUTIONS, Inc.	CHICAGO, IL, US
3005168196	PENUMBRA, INC.	Alameda, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014590707. Last updated year: 2026. Please use registration number 3014590707 when referencing this establishment in official correspondence.