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PHILIPS Affiniti Diagnostic Ultrasound Systems - HSA Registration DE0016806

Access comprehensive regulatory information for PHILIPS Affiniti Diagnostic Ultrasound Systems in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0016806 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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CLASS C
DE0016806
PHILIPS Affiniti Diagnostic Ultrasound Systems
HSA Registration Number: DE0016806
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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.

Device Classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration Information
Registration Number
DE0016806
Registration Date
February 03, 2015
Change Notification Approval Date
February 20, 2025
Retention Due Date
February 02, 2026
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)
Field Generator Stand - Pole Assy PercuNav Tool Connection Unit PercuNav Field Generator Philips PercuNav Accessory Kit for the Adaptive Needle Tracker PercuNav System Control Unit Assembly Affiniti CVx Affiniti 70 S8-3 Transducer S12-4 Transducer L15-7io Transducer C9-2 Transducer C8-5 Transducer 3D9-3v Transducer BP10-5ec Transducer X5-1 Transducer S7-3t Transducer C10-3v 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 Philips PercuNav Patient Tracker Philips PercuNav Adaptive Needle Tracker Philips PercuNav Ultrasound Tracker S8-3t Transducer eL18-4 Transducer L12-4 Transducer Philips PercuNav Endocavity Ultrasound Tracker V6-2 Transducer V6-2 Transducer X8-2t eL18-4 Transducer mC7-2 Transducer L12-3 ERGO Transducer Transducer mC12-3 V9-2 Transducer
Model Identifier(s)
453561453301 453561629131E 453561656541A 453561715772 453561777081 795190 795210 989605361882 989605361892 989605387852 989605391092 989605391922 989605395622 989605395642 989605400802 989605406772 989605409562 989605409582 989605409592 989605412042 989605412052 989605412062 989605412072 989605412082 989605412102 989605413712 989605414122 989605414692 989605418552 989605418972 989605418982 989605427133 989605428073 989605428083 989605431171 989605431531 989605434813 989605435122 989605437982 989605439061 989605455171 989605456291 989605486021 989605492481 989605495721 989606717071