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EUROPattern Classifier - HSA Registration DE0509526

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.

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CLASS B IVD
DE0509526
EUROPattern Classifier
HSA Registration Number: DE0509526
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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.

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 Owner
Short Name
EUROIMMUN Medizinische Labordiagnostika AG
Address
Seekamp 31, 23560 Lรผbeck, 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