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Revo Fc
EUDAMEDClass IIa (EU MDR)
Ref REF 190-80Model REVO FCModel REVO HR, REVO FC, REVO FC 130
Identity
- Trade Name
- REVO FC EUDAMEDSpectral Optical Coherence Tomographer REVO FC EUDAMED
- Device Name
- Spectral Optical Coherence Tomographer EUDAMED
- Model / Reference
- REVO FC EUDAMEDREF 190-80 EUDAMEDREVO HR, REVO FC, REVO FC 130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903293141229 EUDAMED
- Basic UDI-DI
- B-05903293141229 EUDAMED59032931411900FCEP EUDAMED
- Direct Marketing DI
- 05903293141229 EUDAMED
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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 Fc 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-05903293141229 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05903293141229 | Class IIa | Active |
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Manufacturer
- Manufacturer
- OPTOPOL Technology Sp. z o.o.
- EUDAMED SRN
- PL-MF-000004770
Sources (2)
- EUDAMED ea0d36a2-3b26-4f73-b4a6-6726343c82a3 61 fields · synced Jul 8, 2026
- EUDAMED 7e35effa-c418-45bd-ba58-99fd632779ab 61 fields · synced May 18, 2026