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Singapore HSA registration DE0506720

ARJ Medical PyloPlus+ Rapid Urease Test

Singapore flagSingapore·CLASS B IVD·ARJ Medical, Inc.·Registered March 14, 2022
Device classification
Device Class
CLASS B IVD
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0506720
Registration Date
March 14, 2022
Retention Due Date
March 13, 2026
Product description
PyloPlus+ RUT is intended for the qualitative detection of the urease enzyme in gastric mucosal biopsy specimens for the presumptive determination of Helicobacter pylori in symptomatic adult patients.
Product Owner
Name
ARJ Medical, Inc.
Short Name
ARJ Medical, Inc.
Address
209 State Street East, Oldsmar, FL 34677, UNITED STATES
Registrant
Name
SingMed Healthcare Systems
Address
10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Importer
Name
SingMed Healthcare Systems
Address
10 UBI CRESCENT, UBI TECHPARK, #05-18, SINGAPORE 408564
Model information
Model Name(s)
PyloPlus+ Rapid Urease Test for H.pylori
Model Identifier(s)
PYLO-50
About this record

Access comprehensive regulatory information for ARJ Medical PyloPlus+ Rapid Urease Test 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 DE0506720 and owned by ARJ Medical, Inc.. The device was registered on March 14, 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