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Revo Fc 130
EUDAMEDClass IIa (EU MDR)
Ref REF 193-130Model REVO FC 130Model REVO HR, REVO FC, REVO FC 130
Identity
- Trade Name
- REVO FC 130 EUDAMEDSpectral Optical Coherence Tomographer REVO FC 130 EUDAMED
- Device Name
- Spectral Optical Coherence Tomographer EUDAMED
- Model / Reference
- REVO FC 130 EUDAMEDREF 193-130 EUDAMEDREVO HR, REVO FC, REVO FC 130 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903293141328 EUDAMED
- Basic UDI-DI
- B-05903293141328 EUDAMED59032931411900FCEP EUDAMED
- Direct Marketing DI
- 05903293141328 EUDAMED
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden 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 130 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-05903293141328 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-05903293141328 | Class IIa | Active |
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Manufacturer
- Manufacturer
- OPTOPOL Technology Sp. z o.o.
- EUDAMED SRN
- PL-MF-000004770
Sources (2)
- EUDAMED d18ab7ce-715b-41a1-9af5-0d112defe5bd 61 fields · synced Jun 18, 2026
- EUDAMED 147bf5ba-eff8-4adc-8954-7b0a58b3901b 61 fields · synced May 18, 2026