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TERA Dry Eye Imager
EUDAMEDClass IIa (EU MDR)
Ref 42-0002941Model TERA Dry Eye Imager
Identity
- Trade Name
- TERA Dry Eye Imager EUDAMED
- Device Name
- TERA Eye Dry Imager EUDAMED
- Model / Reference
- TERA Dry Eye Imager EUDAMED42-0002941 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08034028770593 EUDAMED
- Basic UDI-DI
- 803402877TOPOGRAPHER1QM EUDAMED
- EMDN Code
- Z12120123 COMPUTERISED CORNEAL TOPOGRAPHS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
TERA Dry Eye Imager by Visia Imaging Srl — 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 | 803402877TOPOGRAPHER1QM | Class IIa | Active |
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Manufacturer
- Manufacturer
- Visia imaging SRL
- EUDAMED SRN
- IT-MF-000015628
Sources (1)
- EUDAMED 71091d6a-9abb-4116-b3ae-468ad5eb6ded 61 fields · synced Jun 18, 2026