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Roffe International BUZUD Glucose Test Strips - HSA Registration DE0510321

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.

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CLASS C
DE0510321
Roffe International BUZUD Glucose Test Strips
HSA Registration Number: DE0510321
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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.

Device 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 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