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HYPHEN Revohem Ristocetin - HSA Registration DE0504563

Access comprehensive regulatory information for HYPHEN Revohem Ristocetin 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 DE0504563 and owned by HYPHEN BioMed. The device was registered on June 05, 2020.

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
DE0504563
HYPHEN Revohem Ristocetin
HSA Registration Number: DE0504563
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Product Description

For in-vitro diagnostic use. Measurement of platelet aggregation.

Device Classification
Device Class
CLASS B IVD
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0504563
Registration Date
June 05, 2020
Change Notification Approval Date
May 15, 2025
Retention Due Date
June 04, 2025
Product Owner
Short Name
HYPHEN BioMed
Address
155 rue d'Eragny, 95000 Neuville-sur-Oise, FRANCE
Registrant
Address
9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Importer
Address
9 TAMPINES GRANDE, #06-18, SINGAPORE 528735
Model Information
Model Name(s)
Pneumatic Unit, PU-17 CS Supply Parts Automated Blood Coagulation Analyzer CS-2100i SB Cuvette SLD mini cup SLD-400A Revohem Ristocetin CS-5100 Supply Parts (EXP) AUTOMATED BLOOD COAGULATION ANALYZER CS-2500 AUTOMATED BLOOD COAGULATION ANALYZER CS-5100 SLD micro Cup
Model Identifier(s)
1330061 6329733 6372511 6410419 AX008688 BC-444-030 BM080218 BV981798 BY990757 CP606567