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PHILIPS PageWriter TC35 Cardiograph - HSA Registration DE0508265

Access comprehensive regulatory information for PHILIPS PageWriter TC35 Cardiograph in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508265 and owned by Philips Medizin Systeme Bรถblingen GmbH. The device was registered on July 04, 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
DE0508265
PHILIPS PageWriter TC35 Cardiograph
HSA Registration Number: DE0508265
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Product Description

The device is intended to acquire multi-channel ECG signals from adult and Pediatric patients from body surface ECG electrodes, and to record, display, analyze and store these ECG signals for review by the user.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0508265
Registration Date
July 04, 2023
Change Notification Approval Date
January 10, 2025
Retention Due Date
July 03, 2025
Product Owner
Short Name
Philips Medizin Systeme Bรถblingen GmbH
Address
Hewlett-Packard Strasse 2, 71034 Bรถblingen, GERMANY
Registrant
Address
622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
Address
622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763
Model Information
Model Name(s)
PageWriter TC35 Cardiograph PageWriter TC35 Cardiograph
Model Identifier(s)
860437 860437