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View-M
EUDAMEDFDA UDIClass I (EU MDR)
Ref VAA-2000PCRef VM-CA-VAA2000-01Model VAA-2000PCERef VM-CA-SCS3200-01Model SCS-3200Ref VAA-2000PCE-2Model VAA-2000PSEModel VLC-1900Ref VLC-1900PRef VAA-2000PS
Identity
- Trade Name
- View-M EUDAMEDVisual Chart System FDA UDISelf Vision Tester FDA UDI
- Generic Name
- Visual acuity light box FDA UDIVision testing/training chart FDA UDI
- Device Name
- Self Vision Tester EUDAMEDVisual Chart System EUDAMEDVLC-1900P 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 VLC-1900P can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-1900P 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 UDIWhen users put their forehead to the forehead sensor, VAA-2000PCE starts the examination automatically. To see the indications (pictures, numbers, Korean Alphabet, Landolt rings and etc.) through the tester’s eyepiece, users keep eyes on the indication in the middle of background and the indications on every sides. Then move the lever to the same indication to the indication in the middle. If users cannot distinguish the indications, push on of the red buttons on the left and right sides to forgive. Then it skips the phase and change to next indication. When the exam finished, the device analyzes user’s choices and give the result data of the exam. Users can check their eyesight data by printing it from device. In addition, the device prevents user’s mistake by voice guidance To start the color-blindness test, touch the 10.1-inch LCD touch-screen at the top of the device. The indications on the center of the screen are displayed on the LCD touch screen. Touch the displayed indication by one-step multiple-choice color vision test, and then the same type of color vision test will be performed in several steps. Users touch the LCD screen to proceed with the test, the test will be completed. After the test is completed, you can print out the results of the color test on the print paper by touching the print button on the touch screen. FDA UDI
- Model / Reference
- VAA-2000PC EUDAMEDVAA-2000PCE EUDAMEDFDA UDIVM-CA-VAA2000-01 EUDAMEDSCS-3200 EUDAMEDFDA UDIVM-CA-SCS3200-01 EUDAMEDVAA-2000PSE EUDAMEDVAA-2000PCE-2 EUDAMEDVLC-1900P EUDAMEDFDA UDIVLC-1900 EUDAMEDVAA-2000PS EUDAMED
- Description
- VLC-1900P 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 VLC-1900P can be performed by wireless remote control or by wired external devices such as the control box of Digital Phoropter. Unlike existing chart projector, VLC-1900P 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 UDIWhen users put their forehead to the forehead sensor, VAA-2000PCE starts the examination automatically. To see the indications (pictures, numbers, Korean Alphabet, Landolt rings and etc.) through the tester’s eyepiece, users keep eyes on the indication in the middle of background and the indications on every sides. Then move the lever to the same indication to the indication in the middle. If users cannot distinguish the indications, push on of the red buttons on the left and right sides to forgive. Then it skips the phase and change to next indication. When the exam finished, the device analyzes user’s choices and give the result data of the exam. Users can check their eyesight data by printing it from device. In addition, the device prevents user’s mistake by voice guidance To start the color-blindness test, touch the 10.1-inch LCD touch-screen at the top of the device. The indications on the center of the screen are displayed on the LCD touch screen. Touch the displayed indication by one-step multiple-choice color vision test, and then the same type of color vision test will be performed in several steps. Users touch the LCD screen to proceed with the test, the test will be completed. After the test is completed, you can print out the results of the color test on the print paper by touching the print button on the touch screen. FDA UDI
Identifiers
- Catalog Number
- SCS-3200 FDA UDIVLC-1900P FDA UDIVAA-2000PCE FDA UDI
- Primary DI / UDI-DI
- 08800074500206 EUDAMED08800074500213 EUDAMEDFDA UDI08800074500046 EUDAMEDFDA UDI08800074500268 EUDAMED08800074500015 EUDAMEDFDA UDI08800074500183 EUDAMED
- Basic UDI-DI
- B-08800074500206 EUDAMEDB-08800074500213 EUDAMEDB-08800074500046 EUDAMED88000745VAAXT EUDAMED88000745VLCYY EUDAMEDB-08800074500183 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 UDIVision testing/training chart FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 886.1150 FDA UDI
- Market of Registration
- Estonia EUDAMEDBulgaria EUDAMEDHungary EUDAMEDFrance 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
View-M 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-08800074500206 | Class I | Active |
| EUDAMED | European Union | CE/MDD | B-08800074500206 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- View-M Technology
- EUDAMED SRN
- KR-MF-000010996
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (12)
- EUDAMED 8b3eaf92-f7ea-4116-b355-ec54d296d6d4 61 fields · synced Jul 29, 2026
- EUDAMED 369b5031-b5d2-4219-8e40-ac3036ff0c14 61 fields · synced May 17, 2026
- EUDAMED f4a65b5a-60c5-4f3b-b03d-de3b96681128 61 fields · synced May 17, 2026
- EUDAMED e4177cae-2068-4a4e-9577-da76a228fe5c 61 fields · synced May 17, 2026
- FDA UDI a668cd70-9e76-4dfe-ba48-e19a6dbb4aa1 35 fields · synced May 24, 2026
- FDA UDI 4ae8fc50-dbe2-4cbc-b24d-9d15afe69474 35 fields · synced May 30, 2026
- FDA UDI 7f4f6ede-f74b-410f-b313-516fe4c32f38 35 fields · synced May 30, 2026
- EUDAMED 8f906fde-feac-453e-9608-8a1dc5e45f5a 61 fields · synced Jul 8, 2026
- EUDAMED 9ac092a3-92bd-466e-8987-ebf7457e4ae6 61 fields · synced Jul 19, 2026
- EUDAMED 7a7f8137-1e35-417d-ad9f-173e99802c01 61 fields · synced Jul 20, 2026
- EUDAMED d0ec5bf0-0962-4d20-87e9-d9dac483d397 61 fields · synced Jul 24, 2026
- EUDAMED bd0fa3e6-5e4e-4602-9c0b-4bd700507aea 61 fields · synced Jul 25, 2026