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Gambro MARS Molecular Absorbents Recirculating System - HSA Registration DE0005800

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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CLASS C
DE0005800
Gambro MARS Molecular Absorbents Recirculating System
HSA Registration Number: DE0005800
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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.

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 Owner
Short Name
Gambro Lundia AB
Address
Box 10101, Magistratsvรคgen 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)
MARSยฎ Treatment Kit - 1112/1 MARSยฎ Treatment Kit - 1412/1 - MARSmini MARS๏ฟฝ Treatment Kit - 1116/1 - X-MARS MARSยฎ Monitor
Model Identifier(s)
800473 800474 800540 MARS Monitor 1TC