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EUDAMED last updated this device on May 29, 2026
081128603PVChartsLFTumbling E, Distance Visual Acuity Test for Testing at 10 Feet is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Precision Vision, Inc.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
008112860331452324US-MF-000008456Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.No certificate specifically references this device's Basic UDI-DI.
(01)00811286033145
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z1212012099INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
View in glossary →081128603PVChartsLFOn the marketTumbling E, 3 Level Contrast Book with 100%, 2.5% and 1.25%081128603PVChartsLFOn the marketTumbling E, 5% Translucent Contrast Chart for 4 Meter (13 foot) Testing.081128603PVChartsLFOn the marketTumbling E, Distance Visual Acuity Test for Testing at 20 Feet081128603PVChartsLFOn the marketTumbling E, ETDRS Style (logarithmic)Translucent Distance Chart for 3 meter (10 foot) Testing (914).081128603PVChartsLFOn the marketTumbling E, ETDRS Style Translucent Chart for 2 meter (6.5 foot) Testing (2425). - SCRAMBLED VERSION A081128603PVChartsLFOn the market