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SunTech Tango M2 Stress BP Monitor - HSA Registration DE0016812

Access comprehensive regulatory information for SunTech Tango M2 Stress BP Monitor in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0016812 and owned by SunTech Medical, Inc.. The device was registered on February 05, 2015.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0016812
SunTech Tango M2 Stress BP Monitor
HSA Registration Number: DE0016812
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Product Description

Tango M2 is a non-invasive blood pressure monitor, with the optional capability to monitor oxygen saturation (SpO2), for use in cardiac or exercise stress testing. It measures and displays a patient's systolic and diastolic blood pressure, and with the SpO2 option, percent oxygen saturation of arterial blood. Use Tango M2 only with adult patients, while they undergo a cardiac or exercise stress test under the supervision of a physician.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0016812
Registration Date
February 05, 2015
Change Notification Approval Date
November 21, 2023
Retention Due Date
February 04, 2026
Product Owner
Short Name
SunTech Medical
Address
507 Airport Boulevard, Suite 117, Morrisville, NC 27560-8200, UNITED STATES
Registrant
Address
2 KALLANG AVENUE, CT HUB, #05-04, SINGAPORE 339407
Importer
Address
2 Kallang Avene, CT Hub, #05-04, SINGAPORE 339407
Model Information
Model Name(s)
Finger Clip Sensor, SpO2, Purelight, Adult, 1 meter CABLE, ECG, BNC to RS232 ECG trigger cable 4240 to MAX 1 RS232 I/F cable BNC ECG trigger cable RS232 comminucations cable BNC to Phono ECG trigger cable ECG splitter cable Tango to Nihon Kohden 9320 RS232 I/F cable Cable assembly - Tango Cable CASE Analog/Digital ECG Interface 8 pin mini din splitter cable Cable, SpO2,LPXpod, 2m Tango M2 Patient Cable WRIST STRAP BLACK POLE CLAMP ASSY. KIT, T-TUBE, NEW CPC-TO-CPC ABP TTube Orbit K Cuff, Small Adult Orbit K Cuff, Adult Orbit K Cuff, Large Adult Orbit K Cuff - Adult Plus Orbit K Cuff, w/Mic, Small Adult Orbit K Cuff, w/Mic - Adult Orbit K Cuff w/Mic. - Large Adult Orbit K Cuff w/Mic,- Adult Plus LPXpod SpO2 Kit w/adult finger sensor, Tango M2 Tango M2 microphone, 18" Tango M2 Microphone, 12 Single Use Patient Kit - Small Adult Disposable Cuff with Female Quick Connects and Mic Pads Single Use Patient Kit - Adult Disposable Cuff with Female Quick Connects and Mic Pads Single Use Patient Kit - Adult Long Disposable Cuff with Female Quick Connects and Mic Pads Single Use Patient Kit - Large Adult Disposable Cuff with Female Quick Connects and Mic Pads Single Use Patient Kit - Large Adult Long Disposable Cuff with Female Quick Connects and Mic Pads Tango M2 USB Cable Kit Tango M2 Preventative Maintenance Kit Tango M2 WW, w/o ECG, no Power cord Tango M2, ECG, WW, no power cord Tango M2 kit, EU Case Tango M2 kit, UK, Case Tango M2 kit, EU/UK, CardioPerfect Tango M2 kit, QStress/Q4500 Tango M2 kit, WW, Xscribe/StressVue
Model Identifier(s)
52-0003-00 91-0004-00 91-0009-00 91-0010-00 91-0011-00 91-0013-00 91-0018-00 91-0053-00 91-0061-00 91-0065-00 91-0066-00 91-0069-00 91-0125-01 91-0127-00 98-0003-00 98-0008-00 98-0030-00 98-0061-01 98-0061-02 98-0061-03 98-0061-05 98-0062-01 98-0062-02 98-0062-03 98-0062-05 98-0233-01 98-0235-00 98-0235-01 98-0700-01 98-0700-02 98-0700-03 98-0700-04 98-0700-05 98-1010-00 99-0027-39 99-0088-02 99-0088-03 99-0132-09 99-0132-10 99-0132-11 99-0132-16 99-0132-18