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Singapore HSA registration DE0018627

Gambro AK 98 Dialysis Machine

Singapore flagSingapore·CLASS C·Gambro Lundia AB·Registered October 04, 2016
Device classification
Device Class
CLASS C
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0018627
Registration Date
October 04, 2016
Change Notification Approval Date
April 18, 2024
Retention Due Date
October 03, 2025
Product description
The AK 98 dialysis machine is intended for use as a single patient machine to perform haemodialysis treatments of patients with renal failure or fluid overload upon prescription by a physician. Patient counseling and teaching of treatment techniques are directly under the supervision and discretion of the physician. The AK 98 dialysis machine is intended for the in-center environment and care in a home healthcare environment.
Product Owner
Name
Gambro Lundia AB
Short Name
Gambro Lundia AB
Address
Box 10101, Magistratsvagen 16, SE-220 10 Lund, Sweden, SWEDEN
Registrant
Name
VANTIVE PTE. LTD.
Address
2 WOODLANDS IND PARK D STREET 2, SINGAPORE 737778
Importer
Name
BAXTER HEALTHCARE (ASIA) PTE LTD VANTIVE PTE. LTD.
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)
BPM Cuff SUNTECH Large BPM Cuff SUNTECH Adult BPM Cuff SUNTECH Small AK 98
Model Identifier(s)
110349 110350 110351 115248
About this record

Access comprehensive regulatory information for Gambro AK 98 Dialysis Machine in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0018627 and owned by Gambro Lundia AB. The device was registered on October 04, 2016.

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