Singapore HSA registration DE0504091
Welch Allyn H3+ Digital Holter Recorder
Singapore·CLASS B·Welch Allyn Inc.·Registered February 06, 2020Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0504091
- Registration Date
- February 06, 2020
- Change Notification Approval Date
- July 01, 2024
- Retention Due Date
- February 05, 2026
Product description
The H3+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of up to 48 hours. Such monitoring is most frequently used for the purpose of prospective and retrospective cardiac data and arrhythmia analysis. Holter analysis is appropriate for the indications: Evaluation of adult patients with symptoms suggesting arrhythmia; Evaluation of adult patients with pacemakers; Reporting of time domain heart rate variability; Evaluation of a patient’s response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery); Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients; Clinical and epidemiological research studies and Infant patient evaluation is limited to QRS detection only.
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 192 PANDAN LOOP, PANTECH BUSINESS HUB, #07-22, SINGAPORE 128381 1 YISHUN AVENUE 7, #00-00, SINGAPORE 768923
Model information
- Model Name(s)
- PAT CBL 10WIRE LEADFORM AHA SNAP PAT CBL 10WIRE LEADFORM IEC SNAP PAT CBL 10WIRE LEADFORM XL AHA SNAP PAT CBL 10WIRE LEADFORM XL IEC SNAP PAT CBL 6WIRE AHA SNAP PAT CBL 6WIRE IEC SNAP PAT CBL H3+ 5WIRE IEC SNAP Patient Cable, H3+ 5 Wire AHA Snap, 69 cm, Gray Patient Cable, H3+ 5 Wire IEC Snap, 69 cm, Gray PAT CBL H3+ 5WIRE SHORT AHA SNAP PAT CBL H3+ 5WIRE SHORT IEC SNAP Patient Cable, H3+ 5 Wire AHA Snap, Short 38 cm, Gray Patient Cable, H3+ 5 Wire IEC Snap, Short 38 cm, Gray Patient Cable, H3+ 5 Wire, 2 Channel, Snap, 69 cm, Gray PAT CBL H3+ SHORT 5WIRE/2CH SNAP Patient Cable, H3+ 5 Wire, 2 Channel, Snap, Short 38 cm, Gray H3PLUS 3-CH 48H MULTLANG AHA H3PLUS 3-CH 7DAY MULTLANG AHA H3PLUS 3-CH 7DAY MULTLANG AHA HS6 SYS NOCONNECT HS6 KIT PDF XML HS6 KIT PDF DICOM HS6 KIT SVR NTERFACE HS6 KIT NOCONNECT HS6 KIT PDF XML HS6 KIT PDF DICOM HS6 KIT SVR INTERFACE HS6 KIT NOCONNECT HS6 SERVER KIT DICOM PDF XML
- Model Identifier(s)
- 9293-017-50 9293-017-51 9293-026-50 9293-026-51 9293-028-50 9293-028-51 9293-036-51 9293-036-52 9293-036-53 9293-036-60 9293-036-61 9293-036-62 9293-036-63 9293-037-51 9293-037-60 9293-037-61 H3PLUS-BAA-XXXXX H3PLUS-CAA-XXXXX H3PLUS-CAD-XXXXX HSCRIBE-6AB-CXXXX HSCRIBE-6AC-CXXXA HSCRIBE-6AC-CXXXB HSCRIBE-6AC-CXXXC HSCRIBE-6AC-CXXXX HSCRIBE-6AC-XXXXA HSCRIBE-6AC-XXXXB HSCRIBE-6AC-XXXXC HSCRIBE-6AC-XXXXX HSERV-6AA-XXXXB
About this record
Access comprehensive regulatory information for Welch Allyn H3+ Digital Holter Recorder in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504091 and owned by Welch Allyn Inc.. The device was registered on February 06, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B