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EUROIMMUN EUROLINE Atopy Screen (IgE) - HSA Registration DE0510648

Access comprehensive regulatory information for EUROIMMUN EUROLINE Atopy Screen (IgE) 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 DE0510648 and owned by EUROIMMUN Medizinische Labordiagnostika AG. The device was registered on April 29, 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
DE0510648
EUROIMMUN EUROLINE Atopy Screen (IgE)
HSA Registration Number: DE0510648
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Product Description

The EUROLINE test kit is used for the diagnosis of sensitisations that may lead to allergy-associated symptoms such as conjunctivitis, rhinitis or gastro-intestinal problems. These symptoms can be caused by misguided immune reactions leading to increased immunoglobulin class E (IgE) antibody concentrations, which are measured by using this test.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0510648
Registration Date
April 29, 2025
Retention Due Date
April 28, 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)
EUROLINE Atopy Screen (IgE) EUROLineScan
Model Identifier(s)
DP 3790-1601 E YG 0006-0101