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DiaMed ID-DiaCell - HSA Registration DE0507790

Access comprehensive regulatory information for DiaMed ID-DiaCell in the Singapore medical device market through Pure Global AI's free database. This CLASS D IVD medical device is registered under HSA registration number DE0507790 and owned by DiaMed GmbH. The device was registered on February 16, 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 D IVD
DE0507790
DiaMed ID-DiaCell
HSA Registration Number: DE0507790
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Product Description

Test cell reagents for antibody screening, single donors, blood group O

Device Classification
Device Class
CLASS D IVD
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0507790
Registration Date
February 16, 2023
Change Notification Approval Date
March 20, 2024
Retention Due Date
February 15, 2026
Product Owner
Short Name
DiaMed GmbH
Address
Pra Rond 23, 1785 Cressier, FR, Switzerland, SWITZERLAND
Registrant
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Importer
Address
3A INTERNATIONAL BUSINESS PARK, ICON@IBP, #11-10/16, SINGAPORE 609935
Model Information
Model Name(s)
ID-DiaCell I-II ID-DiaCell I-II-III Asia ID-DiaCell Pool ID-DiaCell Pool LISS/Coombs LISS/Coombs LISS/Coombs LISS/Coombs Coombs Anti-IgG Coombs Anti-IgG Coombs Anti-IgG Coombs Anti-IgG ID-I Negative Cell ID-Dia (Diego) Positive ID-DiaCell I-II-III ID-DiaCell I-II-III NaCl, Enzyme test and Cold Agglutinins  NaCl, Enzyme test and Cold Agglutinins  NaCl, Enzyme test and Cold Agglutinins  NaCl, Enzyme test and Cold Agglutinins  ID-CellStab ID-CellStab DiaMed Cell Freeze DiaMed Cell Thaw ID-Titration Solution ID-Titration Rack Magnetic Dispenser DiaMed Q.C. System DiaMed Basic Q.C.
Model Identifier(s)
3613 3614 3630 3631 4014 4015 4016 4017 4024 4025 4026 4027 4111 4134 4304 4310 5014 5015 5016 5017 5650 5660 5702 5712 9360 9390 9893 9930 9948