IVD Class DIVDR 2017/746On the marketKitNear-patient testingProfessional testingSingle use
- Manufacturer
- Artron Laboratories Inc.
- Manufacturer SRN
- CA-MF-000028974
- UDI-DI
- 00628347560881
- Basic UDI-DI
- 62834756AL0201025Z
- Reference
- A02-01-322P25
- EMDN
- W0105090201
- EMDN description
- HBSAG - RT & POC
- First on market country
- Romania
- Safety summary (SSCP/SSP)
- AR-SSP-HBsAg-2024 · Rev. 1
- Authorised representative
- MedNet EC-REP GmbH
- Last updated
- 02.07.2026 08:32