EntericBio Gastro Panel 2
by Serosep Limited Ireland EUDAMED
Ref EBGP2A-v2
EMDN W0105070504
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDD | NumberB-05391513879142 | Date26 May 2022 | StatusActive |
Coverage
- Expiring (legacy directive)
- Not covered
European Union — CE/IVDD Expiring (legacy directive)
Specification
- Device Name
- EntericBio Gastro Panel 2 v2
- Model / Reference
- EBGP2A-v2
- Primary DI / UDI-DI
- 05391513879142
- Basic UDI-DI
- B-05391513879142
- EMDN Code
- W0105070504 Gastrointestinal infections - multiplex na reagents
- Device Class
- Class IVD General
- Market of Registration
- Ireland
Manufacturer details
- EUDAMED SRN
- IE-MF-000020322
Other devices from Serosep Limited
Properties & raw data
Show properties, registry sources and raw records
Other properties (8)
- Sterile: No
- Human Tissues: No
- Animal Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
Sources (1)
- EUDAMED 3f2bdbf0-4976-45ca-ab0e-dd8e8eb8160e