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TERA Dry Eye Imager

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 42-0002941USModel TERA Dry Eye Imager

by Visia imaging SRL

Identity

Trade Name
TERA Dry Eye Imager EUDAMEDFDA UDI
Generic Name
Corneal topography system FDA UDI
Device Name
TERA Eye Dry Imager EUDAMED
Model / Reference
TERA Dry Eye Imager EUDAMEDFDA UDI
42-0002941US EUDAMED

Identifiers

Catalog Number
42-0002941US FDA UDI
Primary DI / UDI-DI
08034028770609 EUDAMEDFDA UDI
Basic UDI-DI
803402877TOPOGRAPHER1QM EUDAMED
FDA Product Code
MMQ FDA UDI
EMDN Code
Z12120123 COMPUTERISED CORNEAL TOPOGRAPHS EUDAMED
GMDN Term
Corneal topography system FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I FDA UDI
Regulation Number
886.1350 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

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

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

TERA Dry Eye Imager by Visia Imaging Srl — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Visia imaging SRL
EUDAMED SRN
IT-MF-000015628

Sources (2)

  • EUDAMED 63c34a51-a120-4fe8-9805-d2418c5adb48 61 fields · synced Jul 23, 2026
  • FDA UDI 22833a30-6a94-4bbc-805d-b8c397ed8c81 33 fields · synced May 30, 2026