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EUROIMMUN Calprotectin ELISA - HSA Registration DE0509773

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.

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CLASS B IVD
DE0509773
EUROIMMUN Calprotectin ELISA
HSA Registration Number: DE0509773
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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.

Device 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 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