HSA · registration DE0510648

EUROIMMUN EUROLINE Atopy Screen (IgE)

Name: EUROIMMUN EUROLINE Atopy Screen (IgE) — HSA DE0510648
Creator: EUROIMMUN Medizinische Labordiagnostika AG
Keywords: EUROIMMUN EUROLINE Atopy Screen (IgE), EUROIMMUN EUROLINE Atopy Screen (IgE), DE0510648, Immunology, HSA

SingaporeImmunologyClass BEUROIMMUN Medizinische Labordiagnostika AG

Verified

Official record identity

Registration number: DE0510648
Model name: EUROLINE Atopy Screen (IgE); EUROLineScan
Model identifier: DP 3790-1601 E; YG 0006-0101
Registration date: April 29, 2025

Classification

Risk class: Class B
Published category: Immunology

Published parties

Product owner: EUROIMMUN Medizinische Labordiagnostika AG
Registrant / registration holder: EUROIMMUN (SOUTH EAST ASIA) PTE. LTD.

Official 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.

Additional source fields

Product owner address: Seekamp 31, 23560 Lübeck, Germany
Registrant address: 438A ALEXANDRA ROAD, #02-05/10, ALEXANDRA TECHNOPARK, Singapore 119967

About this record

This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.