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Philips EPIQ Diagnostic Ultrasound System - HSA Registration DE0502183

Access comprehensive regulatory information for Philips EPIQ Diagnostic Ultrasound System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0502183 and owned by Philips Ultrasound LLC. The device was registered on September 21, 2018.

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
DE0502183
Philips EPIQ Diagnostic Ultrasound System
HSA Registration Number: DE0502183
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Product Description

Diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: โ€ข Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intra-cardiac Echo, Intra-luminal, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. โ€ข The clinical environments where EPIQ Series Diagnostic Ultrasound Systems can be used include clinics, hospitals, and clinical point-of-care for diagnosis of patients. โ€ข When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0502183
Registration Date
September 21, 2018
Change Notification Approval Date
May 07, 2025
Retention Due Date
September 20, 2025
Product Owner
Short Name
Philips Ultrasound LLC
Address
22100 Bothell Everett Highway, Bothell, Washington, 98021-8431, UNITED STATES
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)
EPIQ Diagnostic Ultrasound System EPIQ Diagnostic Ultrasound System S8-3 Transducer S12-4 Transducer L15-7io Transducer C9-2 Transducer C8-5 Transducer X5-1 Transducer X7-2 Transducer S7-3t Transducer XL14-3 Transducer X6-1 Transducer L18-5 Transducer C5-1 Transducer D2cwc Transducer D5cwc Transducer L12-3 Transducer S5-1 Transducer D2tcd Transducer X7-2t Transducer L12-5 50 Transducer S8-3t Transducer eL18-4 Transducer X8-2t Transducer eL18-4 Transducer X8-2ti Transducer S9-2 Transducer L12-3 ERGO Transducer Transducer X11-4t X5-1c transducer Transducer C5-1 ml26-8 Transducer
Model Identifier(s)
795231 795232 989605361882 989605361892 989605387852 989605391092 989605391922 989605400802 989605400812 989605406772 989605409251 989605409282 989605409582 989605412042 989605412052 989605412062 989605412072 989605412082 989605412102 989605414122 989605418552 989605431171 989605431531 989605455171 989605456291 989605457831 989605472101 989605492481 989605501821 989606702251 989606714071 989606722361