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Guangdong Transtek Welch Allyn ProBPโ„ข 2000 Digital Blood Pressure Device - HSA Registration DE0504921

Access comprehensive regulatory information for Guangdong Transtek Welch Allyn ProBPโ„ข 2000 Digital Blood Pressure Device in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504921 and owned by Guangdong Transtek Medical Electronics Co., Ltd.. The device was registered on September 15, 2020.

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
DE0504921
Guangdong Transtek Welch Allyn ProBPโ„ข 2000 Digital Blood Pressure Device
HSA Registration Number: DE0504921
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Product Description

The Welch Allyn ProBP 2000 Digital blood pressure device is intended for use in measuring blood pressure and heart rate in patients at least 3 years of age or older with arm circumferences between 15cm to 55cm (approximately 5.9 to 21.7 inches). The Welch Allyn ProBP 2000 automatically measures systolic and diastolic pressure and pulse rate. The device is intended to be used by clinicians and medically qualified personnel.

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0504921
Registration Date
September 15, 2020
Retention Due Date
September 14, 2025
Product Owner
Short Name
Guangdong Transtek Medical Electronics Co., Ltd.
Address
Zone A, No. 105, Dongli Road, Torch Development District, 528437 Zhongshan, Guangdong, CHINA
Registrant
Address
1 YISHUN AVENUE 7, SINGAPORE 768923
Importer
Address
1 YISHUN AVENUE 7, #00-00, SINGAPORE 768923 1 YISHUN AVENUE 7, #00-00, SINGAPORE 768923
Model Information
Model Name(s)
AC ADAPTER WALL MOUNT KIT, PRO-BP 2000 STAND KIT, PRO-BP 2000 HOLSTER KIT, PRO-BP 2000 ProBP 2000 Digital BP Device ProBP 2000 Digital BP Device & Power Supply
Model Identifier(s)
107041 107194 107195 107201 2000 2000-P