Identity
- Trade Name
- DRS FDA UDI
- Generic Name
- Ophthalmic fundus camera FDA UDI
- Device Name
- DRS EUDAMEDFUNDUS CAMERA FDA UDI
- Model / Reference
- ADDRSME002 EUDAMEDDRS FDA UDI
- Description
- FUNDUS CAMERA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08053677040017 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08053677040017 EUDAMED
- 510(k) Number
- K101935 FDA UDI
- FDA Product Code
- HKI 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
- 886.1120 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
No
FDA UDI
Drs by Centervue S.p.a. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08053677040017 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Centervue S.p.a.
- EUDAMED SRN
- IT-MF-000017082
Sources (2)
- EUDAMED cbdc4fca-7548-47f9-b588-b9df41849777 61 fields · synced Jul 15, 2026
- FDA UDI 73eee89b-14cf-4325-b084-95db36514e53 34 fields · synced May 30, 2026