Singapore HSA registration DE0509352
Immundiagnostik IDKmonitor® Adalimumab drug level ELISA
Singapore·CLASS B IVD·Immundiagnostik AG·Registered June 05, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509352
- Registration Date
- June 05, 2024
- Retention Due Date
- June 04, 2025
Product description
This Immundiagnostik AG assay is an enzyme immunoassay intended for the quantitative determination of free adalimumab (therapeutic antibody against TNFα, e. g. HUMIRA®) in EDTA plasma and serum. For in vitro diagnostic use only.
Product Owner
- Short Name
- Immundiagnostik AG
- Address
- Stubenwald-Allee 8a, D‐64625 BENSHEIM, GERMANY
Registrant
- Address
- 1 RAFFLES QUAY, SINGAPORE 048583
Importer
- Address
- 15 CHANGI NORTH WAY, #01-00, SINGAPORE 498770
Model information
- Model Name(s)
- IDKmonitor® Adalimumab drug level ELISA
- Model Identifier(s)
- K 9657
About this record
Access comprehensive regulatory information for Immundiagnostik IDKmonitor® Adalimumab drug level ELISA in the Singapore medical device market through Pure Global AI's free database. This CLASS B IVD medical device is registered under HSA registration number DE0509352 and owned by Immundiagnostik AG. The device was registered on June 05, 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 B IVD