IVD Class AIVDR 2017/746On the marketCompanion diagnosticsDirect markingInstrumentNear-patient testingProfessional testing
- Manufacturer
- Suzhou Helmen Precision Insturments Co.,Ltd
- Manufacturer SRN
- CN-MF-000002230
- UDI-DI
- 06973602150418
- Basic UDI-DI
- 697360215FICNY
- Reference
- FIC-A1600
- EMDN
- W0201020201
- EMDN description
- IMMUNOCHEMISTRY READERS
- First on market country
- -
- Authorised representative
- Lotus NL B.V.
- Last updated
- 16.06.2026 13:19