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IMMUNDIAGNOSTIK REMSIMA® MONITOR TOTAL ADA ELISA - HSA Registration DE0502825

Access comprehensive regulatory information for IMMUNDIAGNOSTIK REMSIMA® MONITOR TOTAL ADA 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 DE0502825 and owned by Immundiagnostik AG. The device was registered on March 04, 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
DE0502825
IMMUNDIAGNOSTIK REMSIMA® MONITOR TOTAL ADA ELISA
HSA Registration Number: DE0502825
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Product Description

This ELISA is intended for the determination of human antibodies against TNFα blocker Remsima® in the presence of 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
DE0502825
Registration Date
March 04, 2019
Change Notification Approval Date
August 07, 2019
Retention Due Date
March 03, 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 total ADA ELISA WASHBUF Remsima® Monitor total ADA ELISA SUB Remsima® Monitor total ADA ELISA STOP Remsima® Monitor total ADA ELISA Remsima® Monitor total ADA ELISA ABBUF Remsima® Monitor total ADA ELISA ASYBUF Remsima® Monitor total ADA ELISA CONJ Remsima® Monitor total ADA ELISA CTRL CUT OFF Remsima® Monitor total ADA ELISA CTRL NEG Remsima® Monitor total ADA ELISA CTRL POS Remsima® Monitor total ADA ELISA PLATE Remsima® Monitor total ADA ELISA TRACER
Model Identifier(s)
K 0001.C.100 WASHBUF K 0002.15 SUB K 0003.15 STOP K 9664 K 9664 ABBUF K 9664 ASYBUF K 9664 CONJ K 9664 CTRL CUTOFF K 9664 CTRL NEG K 9664 CTRL POS K 9664 PLATE K 9664 TRACER