Q-Station Elite
by PROTIA Inc. South Korea EUDAMED
Ref MQST0901
EMDN W0201020101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number880944648QST09SA | Date8 Nov 2022 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/IVDR Active
Specification
- Device Name
- Q-Station Elite
- Model / Reference
- MQST0901
- Primary DI / UDI-DI
- 08809446480276
- Basic UDI-DI
- 880944648QST09SA
- Direct Marketing DI
- 08809446480276
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)
- Device Class
- Class A
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- KR-MF-000026040
- Authorised representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Other devices from PROTIA Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (9)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Reagent: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- New Device: No
Sources (1)
- EUDAMED 4a3fc240-5bf9-4a71-9eef-717a6bf0ef15