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EUROIMMUN Anti-IA2 ELISA (IgG) - HSA Registration DE0510295

Access comprehensive regulatory information for EUROIMMUN Anti-IA2 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 DE0510295 and owned by EUROIMMUN Medizinische Labordiagnostika AG. The device was registered on January 31, 2025.

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
DE0510295
EUROIMMUN Anti-IA2 ELISA (IgG)
HSA Registration Number: DE0510295
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Product Description

The ELISA test kit provides a quantitative in vitro assay for human autoantibodies against tyrosine phosphatase (IA2) in serum or plasma for the diagnosis of Type 1 diabetes mellitus (insulin-dependent diabetes mellitus, IDDM).

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0510295
Registration Date
January 31, 2025
Retention Due Date
January 30, 2026
Product Owner
Short Name
EUROIMMUN Medizinische Labordiagnostika AG
Address
Seekamp 31, 23560 Lรผbeck, 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-IA2 ELISA (IgG)
Model Identifier(s)
EA 1023-9601 G