Singapore HSA registration DE0011566
Abbott Diagnostics Technologies AS NycoCard™ HbA1c
Singapore·CLASS B IVD·Abbott Diagnostics Technologies AS·Registered November 08, 2012Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0011566
- Registration Date
- November 08, 2012
- Change Notification Approval Date
- August 12, 2022
- Retention Due Date
- November 07, 2025
Product description
NycoCard™ HbA1c is an in vitro diagnostic medical device for quantitative determination of glycated haemoglobin (HbA1c) in human whole blood. For monitoring of long term metabolic control in persons with diabetes Mellitus
Product Owner
- Short Name
- Abbott Diagnostics Technologies AS
- Address
- Kjelsasveien 161, P.O. Box 6863 Rodeløkka, NO-0504 Oslo, NORWAY
Registrant
- Address
- 3 FRASER STREET, DUO TOWER, #23-28, SINGAPORE 189352
Importer
- Address
- 6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674 10 UBI CRESCENT, UBI TECHPARK, #06-02, SINGAPORE 408564
Model information
- Model Name(s)
- NycoCard Reader II Power Supply – Mascot T9725 NycoCard™ HbA1c NycoCard™ Reader II NycoCard Reader II Service Kit Reader II Calibration Device (10 units) Reader II Pen Rings (10 units) Reader II Pen Tips (10 units) Reader II Pad Capillary Holder Capillary Tubes, 5µL (1x200 units) Mini-Pet 25µl Mini-Pet 5µl Mini-Pet 50µl NycoCard™ HbA1c Control
- Model Identifier(s)
- 1115738 1116813 1116815 1116816 1116821 1116822 1116823 1116898 1116952 1116953 1116954 1116955 1116956 1116958
About this record
Access comprehensive regulatory information for Abbott Diagnostics Technologies AS NycoCard™ HbA1c 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 DE0011566 and owned by Abbott Diagnostics Technologies AS. The device was registered on November 08, 2012.
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 B IVD