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EUROIMMUN Anti-TSH Receptor (TRAb) Fast ELISA (IgG) - HSA Registration DE0509682

Access comprehensive regulatory information for EUROIMMUN Anti-TSH Receptor (TRAb) Fast ELISA (IgG) 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 DE0509682 and owned by EUROIMMUN Medizinische Labordiagnostika AG. The device was registered on August 23, 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
DE0509682
EUROIMMUN Anti-TSH Receptor (TRAb) Fast ELISA (IgG)
HSA Registration Number: DE0509682
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Product Description

Detection or exclusion and management of the treatment of Graves’ disease.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0509682
Registration Date
August 23, 2024
Retention Due Date
August 22, 2025
Product Owner
Short Name
EUROIMMUN Medizinische Labordiagnostika AG
Address
Seekamp 31, 23560 Lübeck, GERMANY
Registrant
Address
1 CHANGI BUSINESS PARK AVENUE 1, ULTRO BUILDING, #01-01/05, SINGAPORE 486058
Importer
Address
1 CHANGI BUSINESS PARK AVENUE 1, ULTRO BUILDING, #01-01/05, SINGAPORE 486058
Model Information
Model Name(s)
Anti-TSH Receptor (TRAb) Fast ELISA (IgG)
Model Identifier(s)
EA 1015-9601-1 G