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Phadia EliA Parietal Cell Well - HSA Registration DE0508709

Access comprehensive regulatory information for Phadia EliA Parietal Cell Well 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 DE0508709 and owned by Phadia AB. The device was registered on November 30, 2023.

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
DE0508709
Phadia EliA Parietal Cell Well
HSA Registration Number: DE0508709
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Product Description

EliA Parietal Cell is intended for the in vitro quantitative measurement of IgG antibodies directed to parietal cells in human serum and plasma (heparin, citrate, EDTA) to aid in the clinical diagnosis of pernicious anemia. EliA Parietal Cell uses the EliA IgG method on the instruments Phadia 200 and Phadia 250. EliA products are to be used in clinical laboratories by trained professionals only.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0508709
Registration Date
November 30, 2023
Change Notification Approval Date
October 08, 2024
Retention Due Date
November 29, 2025
Product Owner
Short Name
Phadia AB
Address
Rapsgatan 7P, P.O. Box 6460, 751 37 Uppsala, SWEDEN
Registrant
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model Information
Model Name(s)
EliA Parietal Cell Well EliA Gastric Positive Control 250 EliA Gastric Positive Control 200
Model Identifier(s)
14-5669-01 83-1145-01 83-1168-01