HYPHEN Revohem ADP - HSA Registration DE0504614
Access comprehensive regulatory information for HYPHEN Revohem ADP in the Singapore medical device market through Pure Global AI's free database. This CLASS C IVD medical device is registered under HSA registration number DE0504614 and owned by HYPHEN BioMed. The device was registered on June 19, 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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HSA Official Data
CLASS C IVD
DE0504614
HYPHEN Revohem ADP
HSA Registration Number: DE0504614
Product Description
For in-vitro diagnostic use. Measurement of platelet aggregation.
Device Classification
Device Class
CLASS C IVD
Medical Speciality Area
Hematology
Registration Information
Registration Number
DE0504614
Registration Date
June 19, 2020
Change Notification Approval Date
May 15, 2025
Retention Due Date
June 18, 2025
Product Owner
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
Revohem ADP
SLD mini cup SLD-400A
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
AP200422
AX008688
BM080218
BV981798
BY990757
CP606567

