Singapore HSA registration DE0506899
Strong Biotech HelicotecUT®Plus
Singapore·CLASS B IVD·Strong Biotech Corporation·Registered May 31, 2022Device 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 description
To detect the urease enzyme of Helicobacter pylori in gastric mucosal biopsies
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD