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Spectral Optical Coherence Tomographer REVO 80
EUDAMEDClass IIa (EU MDR)
Ref REF 191-80Model REVO 60, REVO 80, REVO nx, REVO nx 130Model REVO 80
Identity
- Trade Name
- Spectral Optical Coherence Tomographer REVO 80 EUDAMEDREVO 80 EUDAMED
- Device Name
- Spectral Optical Coherence Tomographer EUDAMED
- Model / Reference
- REVO 60, REVO 80, REVO nx, REVO nx 130 EUDAMEDREF 191-80 EUDAMEDREVO 80 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903293141236 EUDAMED
- Basic UDI-DI
- 590329314119REVOTA EUDAMEDB-05903293141236 EUDAMED
- Direct Marketing DI
- 05903293141236 EUDAMED
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Spectral Optical Coherence Tomographer REVO 80 by Optopol Technology Sp Z O O — Class IIa — MDD, MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 590329314119REVOTA | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 590329314119REVOTA | Class IIa | Active |
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Manufacturer
- Manufacturer
- OPTOPOL Technology Sp. z o.o.
- EUDAMED SRN
- PL-MF-000004770
Sources (2)
- EUDAMED a3e50e28-e48b-4740-94dc-58c0d69bbb3c 61 fields · synced Jul 24, 2026
- EUDAMED 3c4824f6-cf78-4e28-a7f7-3044efdcc73f 61 fields · synced May 18, 2026