Singapore HSA registration DE0509853
EUROIMMUN IIFT: Myasthenia gravis Mosaic 2
Singapore·CLASS B IVD·EUROIMMUN Medizinische Labordiagnostika AG·Registered September 27, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509853
- Registration Date
- September 27, 2024
- Retention Due Date
- September 26, 2025
Product description
This test kit provides qualitative or semiquantitative in vitro determination of human antibodies of immunoglobulin IgG against acetylcholine receptor and muscle-specific kinase in human serum or plasma to support the diagnosis of myasthenia gravis. This product is designed for use by medical professionals. The results should always be interpreted in connection with further laboratory methods and together with the clinical picture. The product is designed for use as IVD.
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)
- IIFT: Myasthenia gravis Mosaic 2 IIFT: Myasthenia gravis Mosaic 2
- Model Identifier(s)
- FA 1435-1005-2 FA 1435-1010-2
About this record
Access comprehensive regulatory information for EUROIMMUN IIFT: Myasthenia gravis Mosaic 2 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 DE0509853 and owned by EUROIMMUN Medizinische Labordiagnostika AG. The device was registered on September 27, 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD