Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008460104

FEI Number

3008460104

Entity Name

WISTRON MEDICAL TECHNOLOGY CORPORATION

City/State/Country

Zhubei City Hsinchu, TW

Establishment Address

4F-1, 4F-2, 4F-3, 4F-5, 4F-6, No. 150, Sec. 2, Shengyi Rd., Zhubei City Hsinchu 302058, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Wistron Medical Technology Corporation (Owner Number: 10056677)

Owner / Operator Contact Address

4F-1, 4F-2, 4F-3, 4F-5, 4F-6, No. 150, Sec. 2, Shengyi Rd., Zhubei City, TW-HSQ 302058, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BioButton System (Multi-patient Use or MPU) BioButton Rechargeable (BBR) BioButton Rechargeable BioButton MPU BioButton v3 BioButton Charging Station BioButton remote patient monitoring device BioButton wearable device BioButton Rechargeable BioButton BioButton wearable sensor BioButton v3

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2024-11-05
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Cardiovascular	Class 2	870.2300	2024-11-05
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2022-12-22
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2022-12-22

Official Correspondent

Peggy Tsai

US Agent Details

Ho Shan Wang Email: acmebiotechs@gmail.com Phone: (623) 9864377

Related Public Records

Same Entity

Wistron Medical Technology Corporation

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
K131913	Philips Medizin Systeme Boeblingen GmbH	INTELLIVUE CL SPO2 POD AND CL NBP POD, PHILIPS INTELLIVUE PATIENT MONITORS MP5, MP5T, MP5SC	2013-11-26
K832250	Litton Medical Electronics	SERVOMED BASIC BEDSIDE UNIT SMA 102-	1984-06-01
K801515	Abbott Medical Electronics Co.	ABBY II PATIENT MONITOR OR VITAL SIGNS M	1980-07-08

Similar Registrations

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3033118181	CHERO TECHNOLOGY CO., LTD.	Jiaxing Zhejiang, CN
3026960443	Cicor Medtec Bucharest	Bucharest Bucuresti, RO
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB
3012302888	QUIPMENT INC.	Kennesaw, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008460104. Last updated year: 2026. Please use registration number 3008460104 when referencing this establishment in official correspondence.