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IMMUNDIAGNOSTIK REMSIMA® MONITOR DRUG LEVEL ELISA - HSA Registration DE0502810

Access comprehensive regulatory information for IMMUNDIAGNOSTIK REMSIMA® MONITOR 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 DE0502810 and owned by Immundiagnostik AG. The device was registered on February 26, 2019.

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
DE0502810
IMMUNDIAGNOSTIK REMSIMA® MONITOR DRUG LEVEL ELISA
HSA Registration Number: DE0502810
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Product Description

The Immundiagnostik assay is an enzyme immunoassay intended for the quantitative determination of free therapeutic TNFα antibodies Remsima® 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
DE0502810
Registration Date
February 26, 2019
Retention Due Date
February 25, 2026
Product Owner
Short Name
Immundiagnostik AG
Address
Stubenwald-Allee 8a, D‐64625 BENSHEIM, GERMANY
Registrant
Address
1 RAFFLES QUAY, SINGAPORE 048583
Importer
Address
10 RAEBURN PARK, #01-33, SINGAPORE 088702
Model Information
Model Name(s)
Remsima® Monitor drug level ELISA WASHBUF Remsima® Monitor drug level ELISA SUB Remsima® Monitor drug level ELISA STOP Remsima® Monitor drug level ELISA Remsima® Monitor drug level ELISA CONJ Remsima® Monitor drug level ELISA CTRL 1 Remsima® Monitor drug level ELISA CTRL 2 Remsima® Monitor drug level ELISA PLATE Remsima® Monitor drug level ELISA SAMPLEBUF Remsima® Monitor drug level ELISA STD 1-6
Model Identifier(s)
K 0001.C.100 WASHBUF K 0002.15 SUB K 0003.15 STOP K 9665 K 9665 CONJ K 9665 CTRL 1 K 9665 CTRL 2 K 9665 PLATE K 9665 SAMPLEBUF K 9665 STD