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Singapore HSA registration DE0016805

PHILIPS Affiniti Diagnostic Ultrasound System

Singapore flagSingapore·CLASS C·Philips Ultrasound LLC·Registered February 03, 2015
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0016805
Registration Date
February 03, 2015
Change Notification Approval Date
February 19, 2025
Retention Due Date
February 02, 2026
Product description
The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
Product Owner
Name
Philips Ultrasound LLC
Short Name
Philips Ultrasound LLC
Address
22100 Bothell Everett Highway, Bothell, Washington, 98021-8431, 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)
Affiniti 50 Affiniti 30 S8-3 Transducer S12-4 Transducer L15-7io Transducer C8-5 Transducer 3D9-3v Transducer BP10-5ec Transducer S7-3t Transducer L18-5 Transducer VL13-5 Transducer C5-1 Transducer D2cwc Transducer D5cwc Transducer L12-3 Transducer S5-1 Transducer D2tcd Transducer C10-4ec Transducer X7-2t Transducer S4-2 Transducer L12-5 50 Transducer C9-4v Transducer C6-2 Transducer L12-4 Transducer V6-2 Transducer V6-2 Transducer mC7-2 Transducer L12-3 ERGO Tranducer V9-2 Transducer
Model Identifier(s)
795208 795218 989605361882 989605361892 989605387852 989605391922 989605395622 989605395642 989605406772 989605409582 989605409592 989605412042 989605412052 989605412062 989605412072 989605412082 989605412102 989605413712 989605414122 989605414692 989605418552 989605418972 989605418982 989605434813 989605437982 989605439061 989605486021 989605492481 989606717071
About this record

Access comprehensive regulatory information for PHILIPS Affiniti 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 DE0016805 and owned by Philips Ultrasound LLC. The device was registered on February 03, 2015.

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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