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REVO nx
EUDAMEDClass IIa (EU MDR)
Ref REF 192-110Model REVO nxModel REVO 60, REVO 80, REVO nx, REVO nx 130
Identity
- Trade Name
- REVO nx EUDAMEDSpectral Optical Coherence Tomographer REVO nx EUDAMED
- Device Name
- Spectral Optical Coherence Tomographer EUDAMED
- Model / Reference
- REVO nx EUDAMEDREF 192-110 EUDAMEDREVO 60, REVO 80, REVO nx, REVO nx 130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903293141250 EUDAMED
- Basic UDI-DI
- B-05903293141250 EUDAMED590329314119REVOTA EUDAMED
- Direct Marketing DI
- 05903293141250 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
REVO nx by Optopol Technology Sp Z O O — Class IIa — MDR, MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-05903293141250 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05903293141250 | Class IIa | Active |
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Manufacturer
- Manufacturer
- OPTOPOL Technology Sp. z o.o.
- EUDAMED SRN
- PL-MF-000004770
Sources (2)
- EUDAMED 6a99b6f0-5fe2-4fe0-b0e5-fb8d6128d8e6 61 fields · synced Jun 18, 2026
- EUDAMED fc2ab1ce-5d6a-4aa5-807d-7f5335c5a3ea 61 fields · synced May 18, 2026