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Singapore HSA registration DE0504503

Instrumentation Laboratory HemosIL APTT-SP

Singapore flagSingapore·CLASS C IVD·Instrumentation Laboratory Company·Registered May 22, 2020
Device classification
Device Class
CLASS C IVD
Medical Speciality Area
Hematology
Registration information
Registration Number
DE0504503
Registration Date
May 22, 2020
Retention Due Date
May 21, 2025
Product description
For the in vitro determination of Activated Partial Thromboplastin Time (APTT) in citrated plasma on IL Coagulation Systems as a general screening procedure for the evaluation of the intrinsic coagulation pathway and to monitor patients receiving heparin anticoagulant therapy.
Product Owner
Name
Instrumentation Laboratory Company
Short Name
Instrumentation Laboratory Company
Address
180 Hartwell Road, Bedford, MA 01730, 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 APTT-SP (liquid)
Model Identifier(s)
9757600 20003110 20003210 20003310 20003700 20006300
About this record

Access comprehensive regulatory information for Instrumentation Laboratory HemosIL APTT-SP 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 DE0504503 and owned by Instrumentation Laboratory Company. The device was registered on May 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