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Singapore HSA registration DE0006732

AIN MEDICARE RENACARB® BICARBONATE HAEMODIALYSIS CONCENTRATE BP BICARBONATE COMPONENT (SOLUTION B)

Singapore flagSingapore·CLASS C·AIN MEDICARE SDN BHD·Registered May 16, 2011
Device classification
Device Class
CLASS C
Medical Speciality Area
Gastroenterology & Urology
Registration information
Registration Number
DE0006732
Registration Date
May 16, 2011
Change Notification Approval Date
October 29, 2019
Retention Due Date
November 20, 2025
Product description
Acute renal failure; Chronic renal failure; Overhydration; To correct electrolyte and acid base imbalance. In treatment of poisoning, elimination of poisons of low molecular weight e.g. aspirin and certain barbiturate as well as substances of higher molecular weight which diffuse across dialyser membrane, may be hastened by haemodialysis. Treatment of renal failure occurring with P. falciparum infection (malignant tertian malaria).
Product Owner
Name
AIN MEDICARE SDN BHD
Short Name
AIN MEDICARE SDN BHD
Address
JALAN 6/44, KAWASAN PERINDUSTRIAN, PENGKALAN CHEPA 2, 16100, KELANTAN, MALAYSIA
Registrant
Name
JOYSON PTE. LTD.
Address
3 UPPER ALJUNIED LINK, #06-03, SINGAPORE 367902
Importer
Name
JOYSON PTE. LTD.
Address
3 UPPER ALJUNIED LINK, #06-03, SINGAPORE 367902
Model information
Model Name(s)
RENACARB® K1 RENACARB® K1 RENACARB® K2 RENACARB® K2 RENACARB® K3 RENACARB® K3 RENACARB® K4 RENACARB® K4
Model Identifier(s)
BK1 (10L) BK1 (5L) BK2 (10L) BK2 (5L) BK3 (10L) BK3 (5L) BK4 (10L) BK4 (5L)
About this record

Access comprehensive regulatory information for AIN MEDICARE RENACARB® BICARBONATE HAEMODIALYSIS CONCENTRATE BP BICARBONATE COMPONENT (SOLUTION B) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0006732 and owned by AIN MEDICARE SDN BHD. The device was registered on May 16, 2011.

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