Identity
- Trade Name
- RETIA 2 FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- RETIA2 EUDAMEDThe CenterVue Retia 2 Camera is intended for taking digital autofluorescence images of the human retina with and without use of a mydriatic agent to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina. FDA UDI
- Model / Reference
- AINEUME002 EUDAMEDRETIA 2 FDA UDI
- Description
- The CenterVue Retia 2 Camera is intended for taking digital autofluorescence images of the human retina with and without use of a mydriatic agent to aid in the diagnosis and monitoring of diseases and disorders that manifest in the retina. FDA UDI
Identifiers
- Catalog Number
- AINEUME002 FDA UDI
- Primary DI / UDI-DI
- 08053677040086 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08053677040086 EUDAMED
- 510(k) Number
- K180293 FDA UDI
- FDA Product Code
- MYC FDA UDI
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Ophthalmic fundus camera FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.1570 FDA UDI
- Market of Registration
- Italy EUDAMED
- 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Retia2 by Centervue S.p.a. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180293 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08053677040086 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Centervue S.p.a.
- EUDAMED SRN
- IT-MF-000017082
Sources (3)
- EUDAMED 46139f0f-26da-49d5-a85b-6a74f365b3c8 61 fields · synced Aug 4, 2026
- FDA UDI 5eae1f19-1009-4116-9f74-61b9aa55caa6 35 fields · synced May 30, 2026
- FDA 510(k) K180293 1 fields · synced May 18, 2026