Singapore HSA registration DE0510488
Gonotec OSMOMAT 3000 Osmometer
Singapore·CLASS B IVD·Gonotec GmbH·Registered March 20, 2025Device classification
- Device Class
- CLASS B IVD
- Medical Speciality Area
- Clinical chemistry
Registration information
- Registration Number
- DE0510488
- Registration Date
- March 20, 2025
- Retention Due Date
- March 19, 2026
Product description
The Gonotec Osmomat® 3000 cryoscopic osmometer is a non-invasive in-vitro diagnostic device for in-vitro analysis of human blood, serum, urine, semen and other samples, such as drip solutions. Its purpose is to provide information to help identify, diagnose, monitor and treat physiological conditions, states of health, and illnesses.
Product Owner
- Name
- Gonotec GmbH
- Short Name
- Gonotec GmbH
- Address
- Reuchlinstraße 10–11, 10553 Berlin, GERMANY
Registrant
- Address
- 627A ALJUNIED ROAD, BIZTECH CENTRE, #08-09, SINGAPORE 389842
Importer
- Address
- 627A ALJUNIED ROAD, BIZTECH CENTRE, #08-07/09, SINGAPORE 389842
Model information
- Model Name(s)
- GONOTEC Calibration Standard 300mOsmol/kg NaCl/H2O; GONOTEC Calibration Standard 100mOsmol/kg NaCl/H2O GONOTEC Reference Solution OSMOREF® 290mOsmol/kg NaCl/H2O; GONOTEC Calibration Standard 500mOsmol/kg NaCl/H2O; GONOTEC Calibration Standard 850mOsmol/kg NaCl/H2O; GONOTEC Calibration Standard 2000mOsmol/kg NaCl/H2O; GONOTEC OSMOMAT® 3000 GONOTEC OSMOMAT® 3000M GONOTEC OSMOMAT® 3000 D GONOTEC OSMOMAT® 3000 D-M
- Model Identifier(s)
- 30.9.0020 30.9.0100 30.9.0290 30.9.0500 30.9.0850 30.9.2000 32 32.02 32.1 32.12
About this record
Access comprehensive regulatory information for Gonotec OSMOMAT 3000 Osmometer 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 DE0510488 and owned by Gonotec GmbH. The device was registered on March 20, 2025.
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