Singapore HSA registration DE0504056
Welch Allyn® ELI 280® Resting Electrocardiograph
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0504056
- Registration Date
- January 22, 2020
- Change Notification Approval Date
- July 01, 2024
- Retention Due Date
- January 21, 2026
Product description
The ELI 280 Electrocardiograph is a 12-lead diagnostic electrocardiograph capable of acquiring, viewing, transmitting, printing, and storing 12-lead ECG data. • 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
- Short Name
- Welch Allyn, Inc.
- Address
- 4341 State Street Road, Skaneateles Falls, NY 13153, 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)
- ELI280 AM12 AHA BAN WLAN USBD DICOM ELI280 AM12 AHA BAN WLAN USBD DICOM SEC ELI280 AM12 AHA BAN WLAN USBD ELI280 AM12 IEC BAN USB AM12 INTERPRETIVE USB HOST PORT ELI280 AM12 AHA BAN LAN USBD DICOM ELI280 AM12 AHA BAN WLAN USBD ELI280 AM12 AHA BAN LAN USBD ELI280 AM12 AHA BAN LAN USBD DICOM ELI280 AM12 AHA BAN WLAN USBD ELI280 AM12 IEC BAN WLAN USBD DICOM ELI280 AM12 IEC BAN WLAN USBD DICOM ELI280 AM12IEC BAN WLAN USBDPDQ DICOM ELI280 AM12 IEC BAN WLAN USBD ELI280 AM12 IEC BAN LAN USBD DICOM ELI280 AM12 IEC BAN LAN USBD ELI280 WAM AHA BAN USB ELI280 WAM AHA BAN WLAN USBD DICOM ELI280 WAM AHA BAN WLAN USBD DICOM SEC ELI280 WAM AHA BAN WLAN USBD ELI280 WAM IEC BAN LAN USBD ELI280 WAM AHA BAN USB ELI280 WAM IEC BAN WLAN USBD ELI280 WAM AHA BAN WLAN USBD DICOM ELI280 WAM AHA BAN WLAN USBD ELI280 WAM AHA BAN USB ELI280 WAM IEC BAN USB ELI280 WAM IEC BAN LAN USBD DICOM ELI280 WAM IEC BAN LAN USBD ELI280 WAM IEC BAN WLAN USBD DICOM ELI280 WAM IEC BAN WLAN USBD DICOM ELI280 WAM IEC BAN WLAN USBDPDQ DICOM ELI280 WAM IEC BAN WLAN USBD DICOM SEC ELI280 WAM IEC BAN WLAN USBD
- Model Identifier(s)
- ELI280-AAA-AAFBD ELI280-AAA-AAFBT ELI280-AAA-ABFBX ELI280-AAB-ADAAX ELI280-ACB-ADAAX ELI280-BAA-ACCBD ELI280-BBA-ADFAX ELI280-BCA-AACAX ELI280-BCA-ACCBD ELI280-BCA-ADFAX ELI280-BCB-AAFAD ELI280-BCB-AAFBD ELI280-BCB-AAFBG ELI280-BCB-AAFBX ELI280-BDB-AACBD ELI280-BDB-AACBX ELI280-CAA-AAAAX ELI280-CAA-AAFBD ELI280-CAA-AAFBT ELI280-CAA-AAFBX ELI280-CBB-ACCBX ELI280-CCA-AAAAX ELI280-CEB-ACFBX ELI280-DBA-AAFAD ELI280-DCA-AAFAX ELI280-DCA-ACAAX ELI280-DCB-AAAAX ELI280-DCB-AACBD ELI280-DCB-AACBX ELI280-DCB-AAFAD ELI280-DCB-AAFBD ELI280-DCB-AAFBG ELI280-DCB-AAFBT ELI280-DCB-AAFBX
About this record
Access comprehensive regulatory information for Welch Allyn® ELI 280® 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 DE0504056 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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