HSA · registration DE0509526EUROPattern Classifier
SingaporeImmunologyClass BEUROIMMUN Medizinische Labordiagnostika AG
Official record identity
- Registration number
- DE0509526
- Model name
- EUROPattern Classifier
- Model identifier
- YG 0071-0101
- Registration date
- July 15, 2024
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- EUROIMMUN Medizinische Labordiagnostika AG
- Registrant / registration holder
- EUROIMMUN (SOUTH EAST ASIA) PTE. LTD.
Official 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.
Additional source fields
- Product owner address
- Seekamp 31, 23560 Lübeck, Germany
- Registrant address
- 438A ALEXANDRA ROAD, #02-05/10, ALEXANDRA TECHNOPARK, Singapore 119967
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.