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Immundiagnostik IDKmonitor® Adalimumab drug level ELISA - HSA Registration DE0509352

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.

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CLASS B IVD
DE0509352
Immundiagnostik IDKmonitor® Adalimumab drug level ELISA
HSA Registration Number: DE0509352
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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.

Device 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 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