Singapore HSA registration DE0504057
Welch Allyn® ELI 380® Resting Electrocardiograph
Singapore·CLASS B·Welch Allyn Inc.·Registered January 22, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0504057
- Registration Date
- January 22, 2020
- Change Notification Approval Date
- July 01, 2024
- Retention Due Date
- January 21, 2026
Product description
• Device is indicated for use to acquire, analyze, display, and print electrocardiograms. • Device is indicated for use to provide interpretation of the data for consideration by a physician. • Device is indicated for use in a clinical setting, by a physician or by trained personnel who are acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. • The interpretations of ECG offered by the device are only significant when used in conjunction with a physician over-read as well as consideration of all other relevant patient data. • Device is indicated for use on adult and pediatric populations. • The device is not intended to be used as a vital signs physiological monitor.
Product Owner
- Name
- Welch Allyn Inc.
- Short Name
- Welch Allyn Inc.
- Address
- 4341 State Street Road, Skaneateles Falls, NY 13153-0220, UNITED STATES
Registrant
- Address
- 1 YISHUN AVENUE 7, SINGAPORE 768923
Importer
- Address
- 211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552 1 YISHUN AVENUE 7, #00-00, SINGAPORE 768923
Model information
- Model Name(s)
- ELI LINK (Standard form) ELI LINK (Web form) ELI380 LCD WAM LAN USB AHA BAN ELI380 LCD WAM LAN USB IEC BAN ELI380 LCD AM12 LAN USB AHA BAN ELI380 LCD AM12 LAN USB IEC BAN ELI380 LCD AM15E LAN USB AHA BAN ELI380 LCD NOACQMOD LAN USB ELI380 LCD WAM WLAN USB AHA BAN ELI380 LCD WAM WLAN USB IEC BAN ELI380 LCD AM12 WLAN USB AHA BAN ELI380 LCD AM12 WLAN USB IEC BAN ELI380 LCD AM15E WLAN USB AHA BAN ELI380 LCD NOACQMOD WLAN USB ELI380 LCD AM12 WLAN USB DICOM SEC AHA B ELI380 LCD AM12 WLAN USB DICOM SEC IEC B ELI380 LCD WAM WLAN USB DICOM AHA BAN ELI380 LCD WAM WLAN USB DICOM IEC BAN ELI380 LCD AM12 WLAN USB DICOM AHA BAN ELI380 LCD AM12 WLAN USB DICOM IEC BAN ELI380 LCD NOACQMOD WLAN USB DICOM ELI380 ERGO WAM WLAN USB AHA BAN ELI380 ERGO WAM WLAN USB IEC BAN ELI380 ERGO WAM WLAN USB DICM PDQSEC AHA ELI380 ERGO WAM WLAN USB DICM PDQSEC AHA ELI380 ERGO WAM WLAN USB DICOM SEC AHA B ELI380 ERGO AM12 WLAN USB DICOM SEC AHA ELI380 ERGO WAM WLAN USB DICOM AHA BAN ELI380 ERGO WAM WLAN USB DICOM IEC BAN ELI380 ERGO AM15E WLAN USB DICOM AHA BAN ELI380 ERGO AM15E WLAN USB DICOM IEC BAN Eli 380 Optional Upgrades Eli 380 Optional Upgrades Eli 380 Optional Upgrades
- Model Identifier(s)
- 11027-024-50 11027-024-51 ELI380-AAX11 ELI380-AAX12 ELI380-AAX21 ELI380-AAX22 ELI380-AAX43 ELI380-AAXXX ELI380-ABX11 ELI380-ABX12 ELI380-ABX21 ELI380-ABX22 ELI380-ABX43 ELI380-ABXXX ELI380-ACS21 ELI380-ACS22 ELI380-ACX11 ELI380-ACX12 ELI380-ACX21 ELI380-ACX22 ELI380-ACXXX ELI380-DBX11 ELI380-DBX12 ELI380-DCQ11 ELI380-DCQ12 ELI380-DCS11 ELI380-DCS21 ELI380-DCX11 ELI380-DCX12 ELI380-DCX43 ELI380-DCX44 ELI380-XBXXX ELI380-XC1XX ELI380-XCXXX
About this record
Access comprehensive regulatory information for Welch Allyn® ELI 380® Resting Electrocardiograph in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504057 and owned by Welch Allyn Inc.. The device was registered on January 22, 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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