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Singapore HSA registration DE0017248

Agfa CR15-X Digitizer

Singapore flagSingapore·CLASS B·Agfa N.V.·Registered June 16, 2015
Device classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration information
Registration Number
DE0017248
Registration Date
June 16, 2015
Change Notification Approval Date
May 19, 2020
Retention Due Date
June 15, 2025
Product description
Agfa HealthCare CR15-X Digitizer is part of a CR system, further containing a cassette, image plate and modality workstation. The CR system is used in a radiological environment by qualified staff to read-out, process and route static X-ray radiographic images. The digitizer is used to scan an X-ray exposed image plate; it results into a digital image which is sent to the dedicated workstation. Agfa’s Computed Radiography (CR) System with CR 15-X digitizer is not indicated for use in mammography.
Product Owner
Name
Agfa N.V.
Short Name
Agfa N.V.
Address
Septestraat 27, 2640 Mortsel, BELGIUM
Registrant
Name
MEDITECH ASIA ALLIANCE PTE LTD
Address
506 CHAI CHEE LANE, BOXPARK @ CHAI CHEE, #07-02, SINGAPORE 469026
Importer
Name
AGFA HEALTHCARE SINGAPORE PTE LTD MEDITECH ASIA ALLIANCE PTE LTD
Address
62 UBI ROAD 1, OXLEY BIZHUB 2, #08-22, SINGAPORE 408734 506 CHAI CHEE LANE, BOXPARK @ CHAI CHEE, #07-02, SINGAPORE 469026
Model information
Model Name(s)
CR 15-X
Model Identifier(s)
5151/300
About this record

Access comprehensive regulatory information for Agfa CR15-X Digitizer in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0017248 and owned by Agfa N.V.. The device was registered on June 16, 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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