- Role
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EUDAMED last updated this device on May 29, 2026
081128603PVChartsLF2000 Series Revised ETDRS Chart 1 Sloan Letters for 2 meters testing 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.
US-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)00811286032261
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 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
00811286032261Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
081128603PVChartsLF2135UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z1212012099INSTRUMENTS FOR THE ASSESSMENT OF VISUAL FUNCTIONALITY - OTHER081128603PVChartsLFOn the market2.5% Sloan Letters Translucent Contrast Chart for 4 meter (13 foot) Testing.081128603PVChartsLFOn the market2.5% Translucent Contrast Chart for 4 meter (13 foot) Testing.081128603PVChartsLFOn the market2000 Series Revised ETDRS Chart 1 Sloan Letters for 4 meters testing081128603PVChartsLFOn the market2000 Series Revised ETDRS Chart 2 Sloan Letters for 2 meters testing081128603PVChartsLFOn the market2000 Series Revised ETDRS Chart 2 Sloan Letters for 4 meters testing081128603PVChartsLFOn the market