Singapore HSA registration DE0509526
EUROPattern Classifier
Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Immunology
Registration information
- Registration Number
- DE0509526
- Registration Date
- July 15, 2024
- Retention Due Date
- July 14, 2025
Product description
The EUROPattern Classifier software of the manufacturer EUROIMMUN Medizinische Labordiagnostika AG ("EUROIMMUN") is intended to assist trained medical personnel in the evalua-tion of indirect immunofluorescence tests (IFA) by analysing digital images of incubated slides acquired by a compatible fluorescence microscopy system.
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)
- EUROPattern Classifier
- Model Identifier(s)
- YG 0071-0101
About this record
Access comprehensive regulatory information for EUROPattern Classifier 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 DE0509526 and owned by EUROIMMUN Medizinische Labordiagnostika AG. The device was registered on July 15, 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