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SOPRO PSPIX² DIGITAL INTRAORAL IMAGING PLATE SYSTEM - HSA Registration DE0018983

Access comprehensive regulatory information for SOPRO PSPIX² DIGITAL INTRAORAL IMAGING PLATE 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 DE0018983 and owned by SOPRO. The device was registered on February 16, 2017.

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
DE0018983
SOPRO PSPIX² DIGITAL INTRAORAL IMAGING PLATE SYSTEM
HSA Registration Number: DE0018983
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Product Description

The PSPIX system is a laser X-ray device designed to digitize, display and erase imaging plates (IPs) – also known as phosphor plates.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0018983
Registration Date
February 16, 2017
Retention Due Date
February 15, 2026
Product Owner
Name
SOPRO
Short Name
SOPRO
Address
ZAC Athelia IV, Avenue des Genevriers, 13705 La Ciotat, Cedex France, FRANCE
Registrant
Address
5 ANG MO KIO INDUSTRIAL PARK 2A, AMK TECH II, #05-21, SINGAPORE 567760
Importer
Address
5 ANG MO KIO INDUSTRIAL PARK 2A, AMK TECH II, #05-21, SINGAPORE 567760
Model Information
Model Name(s)
Stylus For PSPIX Touchscreen Protective Bag for Imaging Plate Size 0 Protective Bag for Imaging Plate Size 1 Protective Bag for Imaging Plate Size 2 Protective Bag for Imaging Plate Size 3 Bag & Cover for Imaging Plate Size 0 Bag & Cover for Imaging Plate Size 1 Bag & Cover for Imaging Plate Size 2 Bag & Cover for Imaging Plate Size 3 Bag & Cover for Imaging Plate Start Up Kit Standard Imaging Plate Size 0 Standard Imaging Plate Size 1 Standard Imaging Plate Size 2 Imaging Plate Storage Box Standard Imaging Plate Size 3 PSPIX2 Sopro Imaging Software
Model Identifier(s)
5132 700342L 700343L 700344L 700345L 700546 700547 700548 700549 700550 990215 990216 990217 990219 991218 S_702_0001 V 2.33