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Philips Zenition 30 - HSA Registration DE0509516

Access comprehensive regulatory information for Philips Zenition 30 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0509516 and owned by Philips Medical Systems Nederland B.V.. The device was registered on July 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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CLASS C
DE0509516
Philips Zenition 30
HSA Registration Number: DE0509516
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Product Description

The Zenition 30 with flat detector is a mobile X- ray imaging and viewing system. It is designed for medical use in healthcare facilities where X-ray imaging is needed. The system comprises of two main components: the C-arm stand and a mobile view station. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. Applications: • Orthopedic • Neuro • Abdominal • Vascular • Thoracic • Cardiac

Device Classification
Device Class
CLASS C
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0509516
Registration Date
July 12, 2024
Retention Due Date
July 11, 2025
Product Owner
Short Name
Philips Medical Systems Nederland B.V.
Address
Veenpluis 6, 5684 PC Best, NETHERLANDS
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)
Zenition 30
Model Identifier(s)
718076