Singapore HSA registration DE0506340
Welch Allyn H12+ 12-Lead Holter
Singapore·CLASS B·Welch Allyn, Inc.·Registered November 03, 2021Device classification
- Device Class
- CLASS B
- Medical Speciality Area
- Cardiovascular
Registration information
- Registration Number
- DE0506340
- Registration Date
- November 03, 2021
- Change Notification Approval Date
- July 01, 2024
- Retention Due Date
- November 02, 2025
Product description
The H12+ Holter recorder is intended to acquire, record and store ECG data of patients that have been connected to the H12+ recorder and are undergoing Holter monitoring. The H12+ acquires, digitizes and stores data to be analyzed by the HScribe Holter system. The H12+ is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of symptomatic patients requiring ambulatory (Holter) monitoring of up to 48 hours. The H12+ does not perform cardiac analysis by itself and is intended to be used with the HScribe™ Holter analysis system. ECG data pre-recorded by the H12+ is acquired and analyzed by the HScribe Holter analysis system.
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 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 H12PLUS 48H STD-SDMULTLANG AHA 0 H12PLUS 48H STD-SDMULTLANG AHA 0 H12PLUS 48H HF-SDMULTLANG AHA 0 H12PLUS 48H HF-SDMULTLANG AHA 0 HS6 SYS NOCONNECT HS6 KIT PDF XML HS6 KIT PDF DICOM HS6 KIT SVR NTERFACE HS6 KIT NOCONNECT
- Model Identifier(s)
- 9293-017-50 9293-017-51 9293-026-50 9293-026-51 9293-028-50 9293-028-51 H12PLUS-MPA-XXXXX H12PLUS-MPC-XXXXX H12PLUS-OPA-XXXXX H12PLUS-OPC-XXXXX HSCRIBE-6AB-CXXXX HSCRIBE-6AC-CXXXA HSCRIBE-6AC-CXXXB HSCRIBE-6AC-CXXXC HSCRIBE-6AC-CXXXX
About this record
Access comprehensive regulatory information for Welch Allyn H12+ 12-Lead Holter in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0506340 and owned by Welch Allyn, Inc.. The device was registered on November 03, 2021.
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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