Singapore HSA registration DE0510321
Roffe International BUZUD Glucose Test Strips
Singapore·CLASS C·Roffe International Holdings Pte Ltd·Registered February 07, 2025Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0510321
- Registration Date
- February 07, 2025
- Retention Due Date
- February 06, 2026
Product description
The BUZUD Blood Glucose Test Strips are thin strips with a chemical reagent system. They work to measure the glucose concentration with the BUZUD Glucose, Ketone and Uric Acid meter. For in vitro diagnostic use. Test strips are to be used only outside the body for testing purposes. When used for self-testing (over-the-counter testing), the system can accept fresh human capillary whole blood obtained from the fingertip, forearm, and/or palm by non- professional users. Test results serve only as helpful information, not as proof for a clinical diagnosis.
Product Owner
- Short Name
- Roffe International Holdings Pte Ltd
- Address
- 585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Registrant
- Address
- 585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Importer
- Address
- 585 NORTH BRIDGE ROAD, RAFFLES HOSPITAL, #01-02, SINGAPORE 188770
Model information
- Model Name(s)
- BUZUD Glucose Test Strips BUZUD Glucose Control Solution BUZUD Glucose, Ketone and Uric acid meter BUZUD Glucose, Ketone and Uric acid meter
- Model Identifier(s)
- 1026 A-1 MGM-1 MGM-2
About this record
Access comprehensive regulatory information for Roffe International BUZUD Glucose Test Strips in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0510321 and owned by Roffe International Holdings Pte Ltd. The device was registered on February 07, 2025.
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 C