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Spectral Optical Coherence Tomographer REVO nx 130
EUDAMEDClass IIa (EU MDR)
Ref REF 192-130Model REVO 60, REVO 80, REVO nx, REVO nx 130Model REVO nx 130
Identity
- Trade Name
- Spectral Optical Coherence Tomographer REVO nx 130 EUDAMEDREVO nx 130 EUDAMED
- Device Name
- Spectral Optical Coherence Tomographer EUDAMED
- Model / Reference
- REVO 60, REVO 80, REVO nx, REVO nx 130 EUDAMEDREF 192-130 EUDAMEDREVO nx 130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903293141267 EUDAMED
- Basic UDI-DI
- 590329314119REVOTA EUDAMEDB-05903293141267 EUDAMED
- Direct Marketing DI
- 05903293141267 EUDAMED
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Romania 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 nx 130 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 bf236e91-7ca0-4924-9805-e4789774b49a 61 fields · synced Jul 25, 2026
- EUDAMED 7914fe7b-fda8-41f7-a095-8458184440e5 61 fields · synced May 18, 2026