Singapore HSA registration DE0503916
Welch Allyn® ELI 230® Resting Electrocardiograph
Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0503916
- Registration Date
- December 09, 2019
- Change Notification Approval Date
- July 01, 2024
- Retention Due Date
- December 08, 2025
Product description
• Device is indicated for use to acquire, analyze, display, and print electrocardiograms. • Device is indicated for use for patients of any age • Device is indicated for use to provide interpretation of the data for consideration by a 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 physician over read as well as consideration of all other relevant patient data. • The device is not intended to be used as a vital signs physiological monitor. • The cardiac data and analysis provided is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns. • The device is not designed for use in highly invasive environments, such as an operating theatre.
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
Model information
- Model Name(s)
- ELI230 WAM AHA BAN USB ELI230 WAM AHA BAN USB ELI230 WAM AHA BAN USB ELI230 WAM IEC BAN USB ELI230 WAM IEC BAN USB ELI230 WAM AHA BAN USB ELI230 WAM IEC BAN USB ELI230 WAM IEC BAN USB ELI230 WAM IEC BAN USB ELI230 AM12 AHA BAN USB ELI230 AM12 AHA BAN USB AM12 US/CANADA INTPR USB HOST FLASH STD ELI230 AM12 IEC BAN USB ELI230 AM12 IEC BAN USB ELI230 AM12 AHA BAN USB ELI230 AM12 AHA BAN USB ELI230 AM12 IEC BAN USB ELI230 AM12 IEC BAN USB ELI230 AM12 IEC BAN USB
- Model Identifier(s)
- ELI230-AAA-AAAAX ELI230-AAA-ACAAX ELI230-ACA-AAAAX ELI230-ACB-AAAAX ELI230-ACB-ACAAX ELI230-ADA-ACAAX ELI230-ADB-AAAAX ELI230-ADB-ABAAX ELI230-ADB-ACAAX ELI230-BAA-ABAAX ELI230-BAA-ACAAX ELI230-BAB-ADAAX ELI230-BCB-AAAAX ELI230-BCB-ACAAX ELI230-BDA-AAAAX ELI230-BDA-ACAAX ELI230-BDB-AAAAX ELI230-BDB-ABAAX ELI230-BDB-ACAAX
About this record
Access comprehensive regulatory information for Welch Allyn® ELI 230® 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 DE0503916 and owned by Welch Allyn Inc.. The device was registered on December 09, 2019.
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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