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Automated Optical Coherence Tomography and Camera
EUDAMEDClass IIa (EU MDR)
Ref Vision-700
Identity
- Trade Name
- Automated Optical Coherence Tomography and Camera EUDAMED
- Device Name
- Optical Coherence Tomography EUDAMED
- Model / Reference
- Vision-700 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719876420459 EUDAMED
- Basic UDI-DI
- 471987642OPHTHALMICOCTBH EUDAMED
- EMDN Code
- Z12120121 OPTICAL CONSISTENCY TOMOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Automated Optical Coherence Tomography and Camera by Crystalvue Medical Corporation — 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 | 471987642OPHTHALMICOCTBH | Class IIa | Active |
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Manufacturer
- Manufacturer
- Crystalvue Medical Corporation
- EUDAMED SRN
- TW-MF-000018351
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 91db607e-7d1a-44af-8651-30b76c173bdd 61 fields · synced Jun 18, 2026