Singapore HSA registration DE0510648
EUROIMMUN EUROLINE Atopy Screen (IgE)
Singapore·CLASS B IVD·EUROIMMUN Medizinische Labordiagnostika AG·Registered April 29, 2025Device 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 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.
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)
- EUROLINE Atopy Screen (IgE) EUROLineScan
- Model Identifier(s)
- DP 3790-1601 E YG 0006-0101
About this record
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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD