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Singapore HSA registration DE0510531

Ainex ENAD Endoscopy Analysis Software

Singapore flagSingapore·CLASS B·Ainex Corporation·Registered April 01, 2025
Device classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0510531
Registration Date
April 01, 2025
Retention Due Date
March 31, 2026
Product description
The ENAD-DET-01 is an endoscopic image analysis software designed to detect lesion in real-time during endoscopic procedures, but it does not classify the lesions. This software is used during both colonoscopy and gastroscopy procedures to assist medical professionals in identifying lesions.
Product Owner
Name
Ainex Corporation
Short Name
Ainex Corporation
Address
13F, 518, Teheran-ro, Gangnam-gu, Seoul, KOREA, REPUBLIC OF
Registrant
Name
ASIA ACTUAL PTE. LTD.
Address
116 CHANGI ROAD, WIS@CHANGI, #04-05, SINGAPORE 419718
Model information
Model Name(s)
ENAD
Model Identifier(s)
ENAD-DET-01
About this record

Access comprehensive regulatory information for Ainex ENAD Endoscopy Analysis Software in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0510531 and owned by Ainex Corporation. The device was registered on April 01, 2025.

This page provides complete registration details including product owner information, registrant details, 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