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Singapore HSA registration DE0509166

Philips Holter Software

Singapore flagSingapore·CLASS B·Philips Medical Systems·Registered April 12, 2024
Device classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration information
Registration Number
DE0509166
Registration Date
April 12, 2024
Retention Due Date
April 11, 2026
Product description
Holter 2010 Plus and Holter 1810 Series software is a stand-alone software device installed in a user’s PC. The PC then becomes an easy-to-use Holter Scanning System that analyzes ECG, and reports on its findings. Holter 2010 Plus/1810 Series for Windows is intended for use in a hospital or clinical setting, by trained personnel who are acting on the orders of a physician. The scanner evaluates the heartbeats of ambulatory patients recorded over an extended period. The final decision regarding the treatment of patients is the responsibility of the physician
Product Owner
Name
Philips Medical Systems
Short Name
Philips
Address
3000 Minuteman Road, Andover, MA 01810-1099, UNITED STATES
Registrant
Name
PHILIPS ELECTRONICS SINGAPORE PTE LTD
Address
622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
Name
PHILIPS ELECTRONICS SINGAPORE PTE LTD
Address
622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763
Model information
Model Name(s)
Holter Software Holter Hardlock Upgrade
Model Identifier(s)
860292 860323
About this record

Access comprehensive regulatory information for Philips Holter Software in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0509166 and owned by Philips Medical Systems. The device was registered on April 12, 2024.

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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