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Singapore HSA registration DE0504050

Instrumentation Laboratory HemosIL SynthAFax

Singapore flagSingapore·CLASS C IVD·Instrumentation Laboratory Company·Registered January 22, 2020
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0504050
Registration Date
January 22, 2020
Retention Due Date
January 21, 2026
Product description
Intended for in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation Systems, for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
Product Owner
Name
Instrumentation Laboratory Company
Short Name
Instrumentation Laboratory Company
Address
180 Hartwell Road, Bedford MA 01730, United States of America, UNITED STATES
Registrant
Name
BIOMED DIAGNOSTICS PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Importer
Name
BIOMED DIAGNOSTICS PTE LTD
Address
18 BOON LAY WAY, TRADEHUB 21, #05-105, SINGAPORE 609966
Model information
Model Name(s)
HemosIL Factor Diluent HemosIL Normal Control ASSAYED HemosIL Low Abnormal Control ASSAYED HemosIL High Abnormal Control ASSAYED HemosIL Calibration Plasma HemosIL SynthAFax
Model Identifier(s)
9757600 20003110 20003210 20003310 20003700 20007400
About this record

Access comprehensive regulatory information for Instrumentation Laboratory HemosIL SynthAFax 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 DE0504050 and owned by Instrumentation Laboratory Company. The device was registered on January 22, 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.

Free DatabasePowered by Pure Global AIHSA Official DataCLASS C IVD