PureChrom ESBL
by VIAMAR INTERNATIONAL, s.r.o. EUDAMED
Active
Ref 98468-20
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/IVDR | Number85941999298468CX | Date9 Jan 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/IVDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Model / Reference
- 98468-20
- Primary DI / UDI-DI
- 08594199923421
- Basic UDI-DI
- 85941999298468CX
- EMDN Code
- W0104010404 Chromogenic resistance marker media (plates) - mrsa, vre, esbl …
- Device Class
- Class A
- Market of Registration
- Czechia
Manufacturer details
- EUDAMED SRN
- CZ-MF-000038013
Other devices from VIAMAR INTERNATIONAL, s.r.o.
Properties
Other properties (8)
- Sterile: No
- Human Tissues: No
- Microbial Substances: No
- Self Testing: No
- Near-Patient Testing: No
- Companion Diagnostics: No
- Surgical Instrument: No
- New Device: No