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Welch Allyn Diagnostic Cardiology Suite Spirometry - HSA Registration DE0507755

Access comprehensive regulatory information for Welch Allyn Diagnostic Cardiology Suite Spirometry in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507755 and owned by Welch Allyn, Inc.. The device was registered on February 08, 2023.

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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CLASS B
DE0507755
Welch Allyn Diagnostic Cardiology Suite Spirometry
HSA Registration Number: DE0507755
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Product Description

Welch Allyn Diagnostic Cardiology Suite Spirometry is indicated for pulmonary function testing, providing forced expiratory flow-volume and time measurements. The device is intended to be a general assessment tool assisting the clinician in the diagnosis of pulmonary function. These devices are commonly used on patients with occupational exposure to dust or chemicals; presenting with symptoms such as chronic cough, shortness of breath and wheezing; disorders such as interstitial lung disease, bronchitis, asthma, and COPD; or other patients where the clinician determines these pulmonary function measurements are needed. Welch Allyn Diagnostic Cardiology Suite Spirometry is indicated for adult and pediatric patients age 6 years and older and should only be used with patients able to understand the instructions for performing the test.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0507755
Registration Date
February 08, 2023
Change Notification Approval Date
June 25, 2024
Retention Due Date
February 07, 2026
Product Owner
Short Name
Welch Allyn, Inc.
Address
4341 State Street Road, Skaneateles Falls,, NY 13153, United States of America, 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)
WADCS SPIRO Wย ย CALIBR SYRINGE WADCS SPIRO WO CALIBR SYRINGE
Model Identifier(s)
DCSS-CXX DCSS-NXX