Singapore HSA registration DE0510294
EUROIMMUN Anti-Zinc Transporter 8 ELISA
Singapore·CLASS B IVD·EUROIMMUN Medizinische Labordiagnostika AG·Registered January 31, 2025Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0510294
- Registration Date
- January 31, 2025
- Retention Due Date
- January 30, 2026
Product description
The enzyme immunoassay (ELISA) provides quantitative in vitro determination of human autoantibodies against zinc transporter 8 (ZnT8) in serum or plasma to support the diagnosis of type 1 diabetes mellitus (insulin-dependent diabetes mellitus, IDDM). 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)
- Anti-Zinc Transporter 8 ELISA
- Model Identifier(s)
- EA 1027-9601
About this record
Access comprehensive regulatory information for EUROIMMUN Anti-Zinc Transporter 8 ELISA 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 DE0510294 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.
Free DatabasePowered by Pure Global AIHSA Official DataCLASS B IVD