Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014856521

FEI Number

3014856521

Entity Name

TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.

City/State/Country

Taipei City, TW

Establishment Address

6F-2, No. 3-1, YuanQu St., Nangang Dist., Taipei City 115, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Taiwan Aulisa Medical Devices Technologies, Inc. (Owner Number: 10058498)

Owner / Operator Contact Address

6F-2, No. 3-1, YuanQu St., Nangang Dist., Taipei City, TW-TPE 11503, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233963

PMA Number

N/A

All Registered Proprietary Names

System, network and communication, physiological monitorsMonitor, physiological, patient (without arrhythmia detection o OximeterTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY Oximeter Continuous Measurement Thermometer OximeterTRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY Oximeter Oximeter TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCYMonitor, temperature, dialysis Oximeter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2020-11-19
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2020-11-19
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-07-16
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2019-07-16
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-10-04
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-10-30
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-07-16
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2019-07-16
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2019-07-16
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2023-10-25
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-10-25
FLA	Monitor, Temperature, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2023-10-25
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2025-04-11

Official Correspondent

Augustine Lien

US Agent Details

Mark Smutka Email: msmutka@comcast.net Phone: (408) 9817531

Related Public Records

Same Entity

Taiwan Aulisa Medical Devices Technologies, Inc.

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
K071802	Mammendorfer Institut Fur Physik Und Medizin GmbH	TESLA GUARD, MODEL EFT G04	2007-11-09
K124061	Invivo Corporation	MRI PATIENT MONITORING SYSTEM (MODEL 865214)	2013-02-22
K101264	Remote Diagnostic Technologies , Ltd.	TEMPUS IC PROFESSIONAL PATIENT MONITOR	2010-05-11
K113105	Remote Diagnostic Technologies , Ltd.	TEMPUSIC PATIENT MONITOR	2011-12-15
K134014	Remote Diagnostic Technologies , Ltd.	TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE)	2014-08-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2015	Invivo Corporation	2	Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023	Philips North America Llc	2	MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04	GE Medical Systems Information Technologies	2	Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
Z-0042-2015	Mckesson Information Solutions LLC	2	McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Z-2183-2011	Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom	2	TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.

Similar Registrations

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1064859	POLYZEN, LLC	APEX, NC, US
3012103976	TALIS CLINICAL LLC	Streetsboro, OH, US
3006808382	IEI Integration Corp.	Xizhi Dist. Taipei, TW
3043543260	FERRY MACHINE CORPORATION	Oakland, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014856521. Last updated year: 2026. Please use registration number 3014856521 when referencing this establishment in official correspondence.