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Singapore HSA registration DE0506823

Biomérieux VIDAS NEPHROCHECK (NEPH)

Singapore flagSingapore·CLASS C IVD·BIOMERIEUX S.A.·Registered April 25, 2022
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Immunology
Registration information
Registration Number
DE0506823
Registration Date
April 25, 2022
Change Notification Approval Date
June 04, 2024
Retention Due Date
April 24, 2026
Product description
VIDAS® NEPHROCHECK® is an automated test for use on the VIDAS® 3 instrument for the immunoenzymatic quantitative determination of TIMP‑2 (Tissue Inhibitor of Metalloproteinase‑2) and IGFBP‑7 (Insulin-like Growth Factor‑Binding Protein 7) proteins in human urine using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS® NEPHROCHECK® assay is intended to be used in conjunction with clinical evaluation as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) in acutely ill patients.
Product Owner
Name
BIOMERIEUX S.A.
Short Name
BIOMERIEUX S.A.
Address
376,, Chemin de l’Orme 69280, Marcy L Etoile, FRANCE
Registrant
Name
BIOMERIEUX SINGAPORE PTE. LTD.
Address
11 BIOPOLIS WAY, HELIOS, #10-03, SINGAPORE 138667
Importer
Name
BIOMERIEUX SINGAPORE PTE. LTD. Biomerieux Asia Pacific Pte. Ltd.
Address
11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667 11 BIOPOLIS WAY, HELIOS, #10-04, SINGAPORE 138667
Model information
Model Name(s)
VIDAS NEPHROCHECK VIDAS NEPHROCHECK
Model Identifier(s)
421172 421172-03
About this record

Access comprehensive regulatory information for Biomérieux VIDAS NEPHROCHECK (NEPH) in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0506823 and owned by BIOMERIEUX S.A.. The device was registered on April 25, 2022.

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 C IVD