Singapore HSA registration DE0509063
Boditech hemochroma PLUS
Singapore·CLASS B IVD·Boditech Med Inc.·Registered March 15, 2024Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0509063
- Registration Date
- March 15, 2024
- Retention Due Date
- March 14, 2026
Product description
hemochroma PLUS is a portable analyzer intended for use in conjuction with Microcuvettes for quantitative measurement of total hemoglobin in human blood. For in vitro diagnostic use only.
Product Owner
- Short Name
- Boditech Med Inc.
- Address
- 43 Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gang-won-do, 23498, KOREA, REPUBLIC OF
Registrant
- Address
- 6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Importer
- Address
- 6 HARPER ROAD, LEONG HUAT BUILDING, #03-02, SINGAPORE 369674
Model information
- Model Name(s)
- Microcuvettes hemochroma PLUS Control hemochroma PLUS Calibrator hemochroma PLUS
- Model Identifier(s)
- CFPO-27 CFPO-30 CFPO-35 FPRR016
About this record
Access comprehensive regulatory information for Boditech hemochroma PLUS 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 DE0509063 and owned by Boditech Med Inc.. The device was registered on March 15, 2024.
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