Singapore HSA registration DE0509773
EUROIMMUN Calprotectin ELISA
Singapore·CLASS B IVD·EUROIMMUN Medizinische Labordiagnostika AG·Registered September 11, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509773
- Registration Date
- September 11, 2024
- Retention Due Date
- September 10, 2025
Product description
The enzyme immunoassay (ELISA) provides quantitative in vitro determination of calprotectin in human stool samples. 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)
- Calprotectin ELISA
- Model Identifier(s)
- EQ 6831-9601 W
About this record
Access comprehensive regulatory information for EUROIMMUN Calprotectin 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 DE0509773 and owned by EUROIMMUN Medizinische Labordiagnostika AG. The device was registered on September 11, 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