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View-M

EUDAMEDFDA UDI

Class I (EU MDR)

Ref VAA-2000PSERef VM-CA-VAA2000-01

by View-M Technology

Identity

Trade Name
View-M EUDAMED
Self Vision Tester FDA UDI
Generic Name
Vision testing/training chart FDA UDI
Device Name
Self Vision Tester EUDAMED
When users put their forehead to the forehead sensor, VAA-2000PSE 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 FDA UDI
Model / Reference
VAA-2000PSE EUDAMEDFDA UDI
VM-CA-VAA2000-01 EUDAMED
Description
When users put their forehead to the forehead sensor, VAA-2000PSE 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 FDA UDI

Identifiers

Catalog Number
VAA-2000PSE FDA UDI
Primary DI / UDI-DI
08800074500190 EUDAMEDFDA UDI
Basic UDI-DI
88000745VAAXT EUDAMED
B-08800074500190 EUDAMED
FDA Product Code
HOX FDA UDI
EMDN Code
Z12120180 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
GMDN Term
Vision testing/training chart FDA UDI

Classification

Device Class
Class I EUDAMEDFDA UDI
Regulation Number
886.1150 FDA UDI
Market of Registration
France 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

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Manufacturer

Manufacturer
View-M Technology
EUDAMED SRN
KR-MF-000010996
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (3)

  • EUDAMED ebe13f9f-1ec0-47ca-a4a5-4a09febe27bc 61 fields · synced Jun 8, 2026
  • EUDAMED 7323cd91-ec0f-4e05-9200-6473cf4c8940 61 fields · synced May 17, 2026
  • FDA UDI 78ed847b-1ab1-4b2c-bc3a-fa70ffc0c59a 35 fields · synced May 30, 2026