Singapore HSA registration DE0006737
AIN MEDICARE RENACID® BICARBONATE HAEMODIALYSIS CONCENTRATE BP ACIDIC COMPONENT (SOLUTION A)
Singapore·CLASS C·AIN MEDICARE SDN BHD·Registered May 16, 2011Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0006737
- Registration Date
- May 16, 2011
- Change Notification Approval Date
- September 16, 2019
- Retention Due Date
- November 24, 2025
Product description
Bicarbonate Haemodialysis Concentrate BP Acidic Component is intended to be used with Sodium Bicarbonate (Sodium Hydrogen Carbonate) to yield Haemodialysis Solution for haemodialysis treatment. Ready for use Haemodialysis Solution is indicated for; • 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
- 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)
- RENACID® K1 (1 x 10L) RENACID® K1 (1 x 5L) RENACID® K10 (1 x 10L) RENACID® K10 (1 x 5L) RENACID® K10S (1 x 10L) RENACID® K10S (1 x 5L) RENACID® K11 (1 x 10L) RENACID® K11 (1 x 5L) RENACID® K12 (1 x 10L) RENACID® K12 (1 x 5L) RENACID® K13 (1 x 10L) RENACID® K13 (1 x 5L) RENACID® K14 (1 x 10L) RENACID® K14 (1 x 5L) RENACID® K3S (1 x 10L) RENACID® K3S (1 x 5L) RENACID® K4S (1 x 10L) RENACID® K4S (1 x 5L) RENACID® K5 (1 x 10L) RENACID® K5 (1 x 5L) RENACID® K5S (1 x 10L) RENACID® K5S (1 x 5L) RENACID® K6 (1 x 10L) RENACID® K6 (1 x 5L) RENACID® K6S (1 x 10L) RENACID® K6S (1 x 5L) RENACID® K7 (1 x 10L) RENACID® K7 (1 x 5L) RENACID® K7S (1 x 10L) RENACID® K7S (1 x 5L) RENACID® K8S (1 x 10L) RENACID® K8S (1 x 5L) RENACID® K9 (1 x 10L) RENACID® K9 (1 x 5L) RENACID® K9S (1 x 10L) RENACID® K9S (1 x 5L)
- Model Identifier(s)
- K1 (10L) K1 (5L) K10 (10L) K10 (5L) K10S (10L) K10S (5L) K11 (10L) K11 (5L) K12 (10L) K12 (5L) K13 (10L) K13 (5L) K14 (10L) K14 (5L) K3S (10L) K3S (5L) K4S (10L) K4S (5L) K5 (10L) K5 (5L) K5S (10L) K5S (5L) K6 (10L) K6 (5L) K6S (10L) K6S (5L) K7 (10L) K7 (5L) K7S (10L) K7S (5L) K8S (10L) K8S (5L) K9 (10L) K9 (5L) K9S (10L) K9S (5L)
About this record
Access comprehensive regulatory information for AIN MEDICARE RENACID® BICARBONATE HAEMODIALYSIS CONCENTRATE BP ACIDIC COMPONENT (SOLUTION A) in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0006737 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.
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