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Phadia Phadia Analysers - HSA Registration DE0502088

Access comprehensive regulatory information for Phadia Phadia Analysers 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 DE0502088 and owned by Phadia AB. The device was registered on August 29, 2018.

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
DE0502088
Phadia Phadia Analysers
HSA Registration Number: DE0502088
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Product Description

Phadia analysers are fully automated instrument including software to be used together with ImmunoCAP and EliA in vitro diagnostic tests. The instrument is designed to handle processing of samples and reagents.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0502088
Registration Date
August 29, 2018
Change Notification Approval Date
November 18, 2024
Retention Due Date
August 28, 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)
Washing Solution Washing Solution Development Solution Development Solution Stop Solution Maintenance Solution Kit Development Solution Stop Solution Maintenance Solution Kit Large Phadia™ Maintenance Solution Small Phadia™ Maintenance Solution Large Phadia 100 Phadia 250 Dilution Plates Phadia Prime Phadia 200 Dilution Plates, Phadia 200 Dilution Well
Model Identifier(s)
10-9202-01 10-9422-01 10-9440-01 10-9441-01 10-9442-01 10-9476-01 10-9478-01 10-9479-01 10-9537-01 10-9546-01 10-9547-01 12-3500-01 12-3900-01 12-3907-08 12-4101-00 12-4300-00 12-4302-00 14-5614-35