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EUDAMED last updated this device on May 29, 2026
081128603PVChartsLFFrench Colenbrander Low Vision Reading Continuous Text folding Chart. 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-000008456No 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.Primary 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 certificate specifically references this device's Basic UDI-DI.
(01)00811286031189
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.
00811286031189Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
081128603PVChartsLF4019UDI 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 marketFrench Colenbrander folding 100 & 10% contrast continuous text.081128603PVChartsLFOn the marketFrench Colenbrander Low Vision Letter Chart, 1 meter cord and occluder. Copy081128603PVChartsLFOn the marketFRENCH IReST - International Reading Speed Texts081128603PVChartsLFOn the marketFrosted Accessory Lens081128603PVInTLens96On the marketFull Diameter Minus Cylinder Replacement Lens -0.12D081128603PVInTLens96On the market