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Soteria Soteria One Point Zero (version: 1.0) - HSA Registration DE0508945

Access comprehensive regulatory information for Soteria Soteria One Point Zero (version: 1.0) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0508945 and owned by Soteria Biotech Co., Ltd.. The device was registered on February 09, 2024.

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
DE0508945
Soteria Soteria One Point Zero (version: 1.0)
HSA Registration Number: DE0508945
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Product Description

Soteria One Point Zero is a cloud based stand-alone software platform designed to display and analyze head and neck medical images.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Radiology / Imaging
Registration Information
Registration Number
DE0508945
Registration Date
February 09, 2024
Retention Due Date
February 08, 2026
Product Owner
Short Name
Soteria Biotech Co., Ltd.
Address
12F, No. 365, Fude 3rd Rd., Xizhi D, New Taipei City 22151, TAIWAN
Registrant
Address
4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Importer
Address
4 LENG KEE ROAD, SIS BUILDING, #03-03, SINGAPORE 159088
Model Information
Model Name(s)
Soteria One Point Zero (version: 1.0)
Model Identifier(s)
OPZ