Singapore HSA registration DE0502825
IMMUNDIAGNOSTIK REMSIMA® MONITOR TOTAL ADA ELISA
Singapore·CLASS B IVD·Immundiagnostik AG·Registered March 04, 2019Device 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 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
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
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD