Identity
- Trade Name
- DRSplus FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- DRSplus EUDAMEDThe CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color imaging of a human retina without the use of a mydriatic agent. FDA UDI
- Model / Reference
- AXSDRME100 EUDAMEDDRSplus FDA UDI
- Description
- The CenterVue DRSplus is a confocal scanning ophthalmoscope indicated for color imaging of a human retina without the use of a mydriatic agent. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08053677040116 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08053677040116 EUDAMED805367704FundusCameraED EUDAMED
- Direct Marketing DI
- 08053677040116 EUDAMED
- 510(k) Number
- K192113 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
DRSplus by Centervue S.p.a. — Class IIa — FDA_510K, MDR, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213705 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K192113 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | B-08053677040116 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08053677040116 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Centervue S.p.a.
- EUDAMED SRN
- IT-MF-000017082
Sources (4)
- EUDAMED abc0ec3f-885a-40e9-adef-6e4f74ecaaba 61 fields · synced Jul 20, 2026
- EUDAMED 1a356765-d3eb-4e18-ad80-d6cb3cc553cf 61 fields · synced May 17, 2026
- FDA UDI 9d5fc72b-dbaa-4ad0-9e7f-9b1ea8eae888 34 fields · synced May 30, 2026
- FDA 510(k) K213705 1 fields · synced May 18, 2026