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Konica Minolta AeroDR System - HSA Registration DE0012892

Access comprehensive regulatory information for Konica Minolta AeroDR 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 DE0012892 and owned by Konica Minolta, Inc.. The device was registered on May 13, 2013.

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 B
DE0012892
Konica Minolta AeroDR System
HSA Registration Number: DE0012892
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Product Description

Indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The AeroDR SYSTEM is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
HSA Product Code
Refer to CRPNS
HS Code
90221400
Registration Information
Registration Number
DE0012892
Registration Date
May 13, 2013
Change Notification Approval Date
October 02, 2017
Retention Due Date
May 12, 2025
Product Owner
Short Name
Konica Minolta, Inc.
Address
1 Sakura-machi, Hino-shi, Tokyo 191-8511, JAPAN
Registrant
Address
211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Importer
Address
11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589 211 HENDERSON ROAD, HENDERSON INDUSTRIAL PARK, #13-01, SINGAPORE 159552 211 HENDERSON ROAD, 211 HENDERSON, #13-01, SINGAPORE 159552
Model Information
Model Name(s)
AeroDR B-1 AeroDR D-1 AeroDR Stitching Unit R AeroDR Stitching Unit L AeroDR C-1 AeroDR X-1 CS-7 STANDARD SOFTWARE CS-7 HQ Detector License (Max.4) CS-7 STD Detector License (Max.4) CS-7 Wireless LAN Connection CR MED Throughput CR Hi Throughput (Max.15) CS-7 DICOM MWM Connection CS-7 DICOM MPPS Connection CS-7 DICOM STORAGE OUTPUT (MAX. 4) CS-7 DICOM Print (Max.2) CS-7 Media Storage CS-7 Easy Tag Key Setting License CS-7 Detailed Tag Key Setting License CS-7 Detailed Image Setting CS-7 Detailed Annotation AeroDR Portable RF Unit AeroDR Portable UF Unit AeroDR Portable Unit Battery AeroDR P-12 CS-7 AEROSYNC License AeroDR P-11 AeroDR Stitching Unit Marker AeroDR Stitching Slit X-Ray Auto Barrier Unit AeroDR Stitching Mask2.4๏ฝ AeroDR Stitching UT cable 12m AeroDR P-31 AeroDR Battery Charger2 AeroDR P-21 AeroDR P-51 AeroDR P-52 AeroDR Portable UF Detector Charger Kit AeroDR Portable Unit Battery Charger AeroDR Interface Unit2 AeroDR Generator Interface Unit 2 AeroDR Battery Charging Unit AeroDR AC Adapter Kit AeroDR Battery Charging KIT AeroDR Portable RF Unit 2 AeroDR BC Uinit AC Adapter
Model Identifier(s)
A20K A3M4 A3PR A3PT A46J A46K A4C2 A4C4 A4C6 A4CC A4CG A4CJ A4CN A4CR A4CU A4CX A4D0 A4D3 A4D5 A4D7 A4D9 A4RN A4T4 A4T6 A50D A569 A5DP A5EW A5EX A5EY A5F2 A5TE A5TJ A6C3 A6C5 A6C7 A6E7 A6JD A6PD A7RM A7RN A7RR A7RW A7RX A83G