IVD Class CIVDR 2017/746Not intended for EU marketKitNear-patient testingProfessional testingSelf testing
- Manufacturer
- General Life Biotechnology Co., Ltd.
- Manufacturer SRN
- TW-MF-000027109
- UDI-DI
- 04711148336376
- Basic UDI-DI
- 471114833BXM00D2W
- Reference
- BXM04D-CSC21-FDR
- EMDN
- W0201069099
- EMDN description
- VARIOUS RAPID TEST CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS - OTHER
- First on market country
- -
- Safety summary (SSCP/SSP)
- SSP471114833BXM00D2W · Rev. 4
- Authorised representative
- MDSS GmbH
- Last updated
- 29.09.2026 09:30