Identity
- Trade Name
- COMPASS EUDAMEDFDA UDI
- Generic Name
- Perimeter, automatic FDA UDI
- Device Name
- COMPASS EUDAMEDCOMPASS is a scanning ophthalmoscope combined with an automatic perimeter that allows the acquisition of images of the retina, as well as the measurement of retinal threshold sensitivity and the analysis of fixation.. FDA UDI
- Model / Reference
- AMGSDME001 EUDAMEDCOMPASS FDA UDI
- Description
- COMPASS is a scanning ophthalmoscope combined with an automatic perimeter that allows the acquisition of images of the retina, as well as the measurement of retinal threshold sensitivity and the analysis of fixation.. FDA UDI
Identifiers
- Catalog Number
- AMGSDME01 FDA UDI
- Primary DI / UDI-DI
- 08053677040048 EUDAMEDFDA UDI
- Basic UDI-DI
- 805367704PerimeterV7 EUDAMEDB-08053677040048 EUDAMED
- Direct Marketing DI
- 08053677040048 EUDAMED
- 510(k) Number
- K150320 FDA UDI
- FDA Product Code
- HPT FDA UDI
- EMDN Code
- Z1212012003 PERIPHERAL VISION ANALYSERS EUDAMED
- GMDN Term
- Perimeter, automatic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1605 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Perimeter, automatic
Compass by Centervue S.p.a. — Class IIa — FDA_510K, MDD, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150320 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 805367704PerimeterV7 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805367704PerimeterV7 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Centervue S.p.a.
- EUDAMED SRN
- IT-MF-000017082
Sources (4)
- EUDAMED 94680f39-cb63-4cc2-8558-6ab94def11b6 61 fields · synced Jul 9, 2026
- EUDAMED c5db749c-1856-4e41-bfc1-325c6e486723 61 fields · synced May 18, 2026
- FDA UDI 0327c702-73fb-41a9-b2db-cee70200f39c 35 fields · synced May 30, 2026
- FDA 510(k) K150320 1 fields · synced May 18, 2026