Identity
- Device Name
- HP-OCT and accessories EUDAMED
- Model / Reference
- HP-OCT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09369998066353 EUDAMED09358863000011 EUDAMED
- Basic UDI-DI
- 93588630HPOCTYC EUDAMED
- Direct Marketing DI
- 09369998066353 EUDAMED09358863000011 EUDAMED
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa 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
HP-OCT and accessories by Cylite Pty Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K231760 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 93588630HPOCTYC | Class IIa | Active |
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Manufacturer
- Manufacturer
- Cylite Pty Ltd
- EUDAMED SRN
- AU-MF-000008611
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (3)
- EUDAMED 2467785a-c6f5-4e9b-906f-c3016d53832a 61 fields · synced Jul 19, 2026
- EUDAMED c0627d30-5f59-47fe-8378-188e57db4762 61 fields · synced May 19, 2026
- FDA 510(k) K231760 1 fields · synced May 18, 2026