Singapore HSA registration DE0509243
Biokit Alinity c Digitoxin
Singapore·CLASS C IVD·Biokit S.A.·Registered April 29, 2024Device classification
- Device Class
- CLASS C IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509243
- Registration Date
- April 29, 2024
- Retention Due Date
- April 28, 2026
Product description
The Alinity c Digitoxin assay is used for the quantitative determination of digitoxin in human serum on the Alinity c analyzer.
Product Owner
- Name
- Biokit S.A.
- Short Name
- Biokit S.A.
- Address
- Av. Can Montcau 7, 08186 Lliçà d'Amunt, Barcelona, SPAIN
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Model information
- Model Name(s)
- Alinity c Digitoxin Assay File Alinity c Digitoxin Standard Alinity c Digitoxin Controls Alinity c Digitoxin Reagent Kit
- Model Identifier(s)
- 01R11-1A 01R1101 01R1110 01R1122
About this record
Access comprehensive regulatory information for Biokit Alinity c Digitoxin in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0509243 and owned by Biokit S.A.. The device was registered on April 29, 2024.
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 IVD