Identity
- Trade Name
- MARCO EUDAMEDLCD ACUITY DEVICE FDA UDI
- Generic Name
- Visual acuity light box FDA UDI
- Device Name
- LCD ACUITY DEVICE EUDAMEDVisual Chart System EUDAMEDPROVUE is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for PROVUE can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, PROVUE is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination. FDA UDI
- Model / Reference
- PROVUE EUDAMEDFDA UDIVLC-1900 EUDAMED
- Description
- PROVUE is an automatic visual acuity system, stand-alone type, which displays broad range of charts, based on LCD panel, including red /green for the eye optometry. The chart rotation for PROVUE can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, PROVUE is able to provide wider range of charts (more than 100 kinds of general and special charts) on LCD panel and the product can be adjusted at the level of the patients for precise examination. FDA UDI
Identifiers
- Catalog Number
- PROVUE FDA UDI
- Primary DI / UDI-DI
- 08800074500152 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08800074500152 EUDAMED88000745VLCYY EUDAMED
- FDA Product Code
- HOX FDA UDI
- EMDN Code
- Z12120180 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
- GMDN Term
- Visual acuity light box FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1150 FDA UDI
- Market of Registration
- Greece 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
No
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
Yes
FDA UDI
Marco by View-M Technology — Class I — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08800074500152 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08800074500152 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- View-M Technology
- EUDAMED SRN
- KR-MF-000010996
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 80166344-f6ca-4e6d-94b8-984e185847ca 61 fields · synced Jul 17, 2026
- EUDAMED 073db4ae-5292-4f1c-a26e-11f3da1101f7 61 fields · synced May 19, 2026
- FDA UDI 7263aeda-6dc9-401e-89db-d7a6ab8c4853 36 fields · synced May 22, 2026