Singapore HSA registration DE0005919
Gambro AK 96® System
Singapore·CLASS C·Gambro Lundia AB·Registered January 07, 2011Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
- HSA Product Code
- Refer to CRPNS
- HS Code
- 90189030
Registration information
- Registration Number
- DE0005919
- Registration Date
- January 07, 2011
- Change Notification Approval Date
- April 18, 2024
- Retention Due Date
- January 06, 2026
Product description
The Gambro AK 96 dialysis machine is intended for use as a single patient machine to perform hemodialysis treatments of patients with renal failure or fluid overload upon prescription by a physician. Patient counselling and teaching of treatment techniques are directly under the supervision and discretion of the physician. The AK 96 dialysis machine is intended for the In-Center environment and for self-care, for example in home environment, on the condition that the hemodialysis is performed by a qualified and competent person, as prescribed by a physician.
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)
- AK 96 AK 96 AK 96 AK 96 AK 96 AK 96 AK 96 AK 96 Blood Pressure Monitor (BPM) Diascan UFD Kit Upgrade Kit
- Model Identifier(s)
- 110374 110375 110655 110656 114739 114740 114741 114742 K40216001 K40217001 K40224001 K40411001
About this record
Access comprehensive regulatory information for Gambro AK 96® 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 DE0005919 and owned by Gambro Lundia AB. The device was registered on January 07, 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