Singapore HSA registration DE0501257
Gambro Lundia AK 98 Dialysis Machine
Singapore·CLASS C·Gambro Lundia AB·Registered February 14, 2018Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0501257
- Registration Date
- February 14, 2018
- Change Notification Approval Date
- April 18, 2024
- Retention Due Date
- February 13, 2026
Product description
The Baxter AK 98 dialysis machine is intended for use for hemodialysis treatments of patients with renal failure or fluid overload upon prescription by a physician. The AK 98 hemodialysis machine is indicated to be used on patients with a body weight of 25 kg or more. The AK 98 dialysis machine is intended for the In-Center environment and care in a Home Healthcare Environment. Patient counseling and teaching of treatment techniques are directly under the supervision and discretion of the 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 98 AK 98
- Model Identifier(s)
- 955403 955603
About this record
Access comprehensive regulatory information for Gambro Lundia 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 DE0501257 and owned by Gambro Lundia AB. The device was registered on February 14, 2018.
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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