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Singapore HSA registration DE0504224

Konica Minolta AeroDR DIRECT DIGITIZER SKR 4000

Singapore flagSingapore·CLASS B·Konica Minolta, Inc.·Registered March 13, 2020
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0504224
Registration Date
March 13, 2020
Change Notification Approval Date
April 14, 2023
Retention Due Date
March 12, 2026
Product description
This device is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in general-purpose diagnostic procedures. This device is not indicated for use in mammography, fluoroscopy, and angiography applications.
Product Owner
Name
Konica Minolta, Inc.
Short Name
Konica Minolta, Inc.
Address
1 Sakura-machi, Hino-shi, Tokyo 191-8511, JAPAN
Registrant
Name
Gold Lite Pte Ltd
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Name
GE HEALTHCARE PTE. LTD. Gold Lite Pte Ltd
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589 211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552
Model information
Model Name(s)
ImagePilot Standard Software Touch AeroDR Direct Digitizer SKR 4000 P-41 AeroDR Direct Digitizer SKR 4000 P-41 ImagePilot STANDARD SOFTWARE
Model Identifier(s)
A4H8 ACNN ACX9 K5G3
About this record

Access comprehensive regulatory information for Konica Minolta AeroDR DIRECT DIGITIZER SKR 4000 in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0504224 and owned by Konica Minolta, Inc.. The device was registered on March 13, 2020.

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