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Strong Biotech HelicotecUT®Plus - HSA Registration DE0506899

Access comprehensive regulatory information for Strong Biotech HelicotecUT®Plus in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0506899 and owned by Strong Biotech Corporation. The device was registered on May 31, 2022.

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 IVD
DE0506899
Strong Biotech HelicotecUT®Plus
HSA Registration Number: DE0506899
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Product Description

To detect the urease enzyme of Helicobacter pylori in gastric mucosal biopsies

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Gastroenterology & Urology
Registration Information
Registration Number
DE0506899
Registration Date
May 31, 2022
Retention Due Date
May 30, 2025
Product Owner
Short Name
Strong Biotech Corporation
Address
2F, No.89, Zhongcheng Rd.,, Tucheng Dist.,, New Taipei City 23674, TAIWAN
Registrant
Address
24 SIN MING LANE, MIDVIEW CITY, #05-91, SINGAPORE 573970
Importer
Address
24 SIN MING LANE, MIDVIEW CITY, #05-91, SINGAPORE 573970
Model Information
Model Name(s)
HelicotecUT Plus
Model Identifier(s)
HUP01