Spectral Optical Coherence Tomographer REVO2 80
by OPTOPOL Technology Sp. z o.o. Poland EUDAMED
Ref REF 224-80Model REVO 60, REVO 80, REVO nx, REVO nx 130, REVO2 60, REVO2 80, REVO2 nx 130 EMDN Z12120121
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number590329314119REVOTA | Date12 Dec 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Spectral Optical Coherence Tomographer
- Model / Reference
- REVO 60, REVO 80, REVO nx, REVO nx 130, REVO2 60, REVO2 80, REVO2 nx 130, REF 224-80
- Primary DI / UDI-DI
- 05903293141076
- Basic UDI-DI
- 590329314119REVOTA
- Direct Marketing DI
- 05903293141076
- EMDN Code
- Z12120121 Optical consistency tomographs
- Device Class
- Class IIa
- Market of Registration
- Poland
Manufacturer details
- EUDAMED SRN
- PL-MF-000004770
Other devices from Optopol Technology Sp Z O O
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 05903293141076|590329314119REVOTA