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Singapore HSA registration DE0507021

FUJIFILM ARIETTA 650 Diagnostic Ultrasound System

Singapore flagSingapore·CLASS B·FUJIFILM CORPORATION·Registered June 28, 2022
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0507021
Registration Date
June 28, 2022
Change Notification Approval Date
September 05, 2024
Retention Due Date
June 27, 2025
Product description
This system is intended to be used by qualified medical doctors and any qualified persons by national law for performing tomographic and hemodynamics diagnoses in the following parts of the human body: • Abdominal • Cardiac • Obstetrics/Gynecology • Superficial organs • Urology • Intraoperative
Product Owner
Name
FUJIFILM CORPORATION
Short Name
FUJIFILM
Address
26-30 nishiazabu 2 chome, MINATO-KU TOKYO 106-8620 JAPAN, JAPAN
Registrant
Name
FUJIFILM HEALTHCARE ASIA PACIFIC PTE LTD
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Importer
Name
FUJIFILM HEALTHCARE ASIA PACIFIC PTE LTD
Address
10 NEW INDUSTRIAL ROAD, FUJIFILM BUILDING, SINGAPORE 536201
Model information
Model Name(s)
ARIETTA 650 C22K C22P C23 C23RV C251 C252 C253 C253A C25P C35 C41 C41B C41L47RP C41RP C41V C41V1 C42 C42K C42T CC41R CC41R1 CC41R2 CL4416R CL4416R1 L31KP L34 L43K L441 L442 L44K L44LA L46K1 L51K L53K L55 L64 R41R S11 S211 S31 S31KP S3ESEL S3ESL1 S42 UST-2265-2 VC35 VC41V
Model Identifier(s)
ARIETTA 650 C22K C22P C23 C23RV C251 C252 C253 C253A C25P C35 C41 C41B C41L47RP C41RP C41V C41V1 C42 C42K C42T CC41R CC41R1 CC41R2 CL4416R CL4416R1 L31KP L34 L43K L441 L442 L44K L44LA L46K1 L51K L53K L55 L64 R41R S11 S211 S31 S31KP S3ESEL S3ESL1 S42 UST-2265-2 VC35 VC41V
About this record

Access comprehensive regulatory information for FUJIFILM ARIETTA 650 Diagnostic Ultrasound System in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0507021 and owned by FUJIFILM CORPORATION. The device was registered on June 28, 2022.

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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS B