Singapore HSA registration DE0005800
Gambro MARS Molecular Absorbents Recirculating System
Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- Gastroenterology & Urology
Registration information
- Registration Number
- DE0005800
- Registration Date
- December 19, 2010
- Change Notification Approval Date
- April 18, 2024
- Retention Due Date
- December 18, 2025
Product description
The MARS method is used to remove protein-bound and/or water-soluble toxins from the blood, primarily in patients with acute or chronic liver failure, frequently accompanied by endogenous intoxication, jaundice (icterus) or comatose conditions.
Product Owner
- Name
- Gambro Lundia AB
- Short Name
- Gambro Lundia AB
- Address
- Box 10101, Magistratsvägen 16, SE-220 10 Lund, SWEDEN
Registrant
- Address
- 2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Importer
- Address
- 150 BEACH ROAD, GATEWAY WEST, #30-01/08, SINGAPORE 189720 2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Model information
- Model Name(s)
- MARS® Treatment Kit - 1112/1 MARS® Treatment Kit - 1412/1 - MARSmini MARS� Treatment Kit - 1116/1 - X-MARS MARS® Monitor
- Model Identifier(s)
- 800473 800474 800540 MARS Monitor 1TC
About this record
Access comprehensive regulatory information for Gambro MARS Molecular Absorbents Recirculating System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0005800 and owned by Gambro Lundia AB. The device was registered on December 19, 2010.
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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