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Phadia EliA SymphonyS Well - HSA Registration DE0506009

Access comprehensive regulatory information for Phadia EliA SymphonyS 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 DE0506009 and owned by Phadia AB. The device was registered on July 23, 2021.

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
DE0506009
Phadia EliA SymphonyS Well
HSA Registration Number: DE0506009
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Product Description

EliA SymphonyS is intended for the in vitro qualitative measurement of antinuclear IgG antibodies in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren's syndrome, scleroderma and polymyositis/dermatomyositis. EliA SymphonyS uses the EliA IgG method on the instrument Phadia 100, 200, 250.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Immunology
Registration Information
Registration Number
DE0506009
Registration Date
July 23, 2021
Change Notification Approval Date
April 30, 2025
Retention Due Date
July 22, 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 IgG Calibrator Well EliA Dummy Well EliA SymphonyS Well EliA IgG Calibrators EliA IgG Curve Control EliA IgG Conjugate EliA Sample Diluent EliA IgG Conjugate EliA IgG Calibrator Strips EliA IgG Curve Control Strips EliA IgG Conjugate 50 EliA IgG Conjugate 200 EliA Sample Diluent EliA ANA Positive Control 250 EliA IgG/IgA/IgM Negative Control 250 EliA ANA Positive Control 100 EliA IgG/IgM/IgA Negative Control 100 EliA Sample Diluent EliA ANA Positive Control 200 EliA IgG/IgA/IgM Negative Control 200
Model Identifier(s)
14-5509-01 14-5510-01 14-5671-01 83-1000-01 83-1001-01 83-1002-01 83-1003-01 83-1005-01 83-1015-01 83-1016-01 83-1017-01 83-1018-01 83-1023-01 83-1033-01 83-1037-01 83-1038-01 83-1042-01 83-1144-01 83-1148-01 83-1157-01