HSA · registration DE0502088Phadia Phadia Analysers
SingaporeImmunologyClass BPhadia AB
Official record identity
- Registration number
- DE0502088
- Model name
- Washing Solution; Washing Solution; Development Solution; Development Solution; Stop Solution; Maintenance Solution Kit; Stop Solution; Maintenance Solution Kit Large; Phadia™ Maintenance Solution Small; Phadia™ Maintenance Solution Large; Phadia 250; Dilution Plates; Phadia Prime; Phadia 200; Dilution Plates, Phadia 200; Dilution Well
- Model identifier
- 10-9202-01; 10-9422-01; 10-9440-01; 10-9441-01; 10-9442-01; 10-9476-01; 10-9479-01; 10-9537-01; 10-9546-01; 10-9547-01; 12-3900-01; 12-3907-08; 12-4101-00; 12-4300-00; 12-4302-00; 14-5614-35
- Registration date
- August 29, 2018
- Source update date
- December 18, 2025
Classification
- Risk class
- Class B
Official value: CLASS B
Published parties
- Product owner
- Phadia AB
- Registrant / registration holder
- BIOMED DIAGNOSTICS PTE LTD
Official 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.
Additional source fields
- Product owner address
- Rapsgatan 7P, P.O. Box 6460, 751 37 Uppsala, Sweden
- Registrant address
- 18 BOON LAY WAY, #05-105, TRADEHUB 21, Singapore 609966
About this record
This page mirrors one row from HSA’s official registered-medical-device workbook. Product owner and registrant are separate published roles; neither is relabeled as the manufacturer. The official NOT_GENERATED value is retained when HSA does not publish a registration number, and the device name remains part of the stable record identity.