Identity
- Trade Name
- Topography Lens EUDAMED
- Device Name
- HP-OCT and accessories EUDAMED
- Model / Reference
- HP-OCT EUDAMEDTL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09358863010027 EUDAMED
- Basic UDI-DI
- 93588630HPOCTYC EUDAMED
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
Topography Lens by Cylite Pty Ltd — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- EUDAMED 76f7af79-4c9d-45c5-a2a6-f50ed09c4d36 61 fields · synced Jun 17, 2026