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Singapore HSA registration DE0505374

Welch Allyn® Spot Vital Signs 4400

Singapore flagSingapore·CLASS B·Welch Allyn, Inc.·Registered January 21, 2021
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0505374
Registration Date
January 21, 2021
Change Notification Approval Date
May 06, 2022
Retention Due Date
January 20, 2026
Product description
The Welch Allyn® Spot Vital Signs 4400 (device) is intended to be used by clinicians and medically qualified personnel for operator initiated spot-check/single measurement of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in oral, rectal and axillary modes of adult and pediatric patients down to 29 days of age. The intended use locations for patients to be measured are physician’s offices, general hospital and alternate care environments.
Product Owner
Name
Welch Allyn, Inc.
Short Name
Welch Allyn, Inc.
Address
4341 State Street Road, Skaneateles Falls, NY 13153, UNITED STATES
Registrant
Name
Welch Allyn Singapore Pte. Ltd.
Address
1 YISHUN AVENUE 7, SINGAPORE 768923
Importer
Name
Gold Lite Pte Ltd WELCH ALLYN SINGAPORE PTE. LTD.
Address
211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552 1 YISHUN AVENUE 7, #00-00, SINGAPORE 768923
Model information
Model Name(s)
PROBE WELL KIT OEM ORAL 9' PROBE WELL KIT OEM RECTAL 9' M031 PROBE COVER CLEAR 7.5K SPOT 4400 35 WATT POWER SUPPLY SPOT 4400 W NIBP SURETEMP NONIN PLUG UK SPOT 4400 WITH NIBP AND SURETEMP PLUG UK GS 777 INT'D DIAG SYS W/PANOP FOR 4400 GS 777 INT'D DIAG SYS FOR 4400
Model Identifier(s)
02895-000 02895-100 05031-750 4400-PS 44WT-4 44XT-4 77794-2M4400 77794-M4400
About this record

Access comprehensive regulatory information for Welch Allyn® Spot Vital Signs 4400 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0505374 and owned by Welch Allyn, Inc.. The device was registered on January 21, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B