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Spectral Optical Coherence Tomographer REVO HR
EUDAMEDClass IIa (EU MDR)
Ref REF 194-130Model REVO HR, REVO FC, REVO FC 130Model REVO HR
Identity
- Trade Name
- Spectral Optical Coherence Tomographer REVO HR EUDAMEDREVO HR EUDAMED
- Device Name
- Spectral Optical Coherence Tomographer EUDAMED
- Model / Reference
- REVO HR, REVO FC, REVO FC 130 EUDAMEDREF 194-130 EUDAMEDREVO HR EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05903293141380 EUDAMED
- Basic UDI-DI
- 59032931411900FCEP EUDAMEDB-05903293141380 EUDAMED
- Direct Marketing DI
- 05903293141380 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 HR 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 | 59032931411900FCEP | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 59032931411900FCEP | Class IIa | Active |
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Manufacturer
- Manufacturer
- OPTOPOL Technology Sp. z o.o.
- EUDAMED SRN
- PL-MF-000004770
Sources (2)
- EUDAMED ed5c6839-0343-4416-8e1f-5965a32888a9 61 fields · synced Aug 3, 2026
- EUDAMED 2b40ec74-4a91-4e12-9ac7-8967668012b0 61 fields · synced May 18, 2026