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US-MF-000035001EyeOn-14WE is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by EyeTech Digital Systems. Placed on the EU market in Northern Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 18, 2023
++B862EYEON14WED4Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
+B862EYEON14WE0D
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.
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 XI; available across 21 countries total.
| Country | On market since | Until |
|---|---|---|
| XIPrimary placement | Apr 15, 2020 | Apr 15, 2025 |
| Austria | Apr 15, 2020 | Apr 15, 2025 |
| Belgium | Apr 15, 2020 | Apr 15, 2025 |
| Bulgaria | Apr 15, 2020 | Apr 15, 2025 |
| Czechia | Apr 15, 2020 | Apr 15, 2025 |
| Germany | Apr 15, 2020 | Apr 15, 2025 |
| Denmark | Apr 15, 2020 | Apr 15, 2025 |
| Estonia | Apr 15, 2020 | Apr 15, 2025 |
| Spain | Apr 15, 2020 | Apr 15, 2025 |
| Finland | Apr 15, 2020 | Apr 15, 2025 |
| France | Apr 15, 2020 | Apr 15, 2025 |
| Croatia | Apr 15, 2020 | Apr 15, 2025 |
| Hungary | Apr 15, 2020 | Apr 15, 2025 |
| Ireland | Apr 15, 2020 | Apr 15, 2025 |
| Iceland | Apr 15, 2020 | Apr 15, 2025 |
| Italy | Apr 15, 2020 | Apr 15, 2025 |
| Netherlands | Apr 15, 2020 | Apr 15, 2025 |
| Norway | Apr 15, 2020 | Apr 15, 2025 |
| Portugal | Apr 15, 2020 | Apr 15, 2025 |
| Sweden | Apr 15, 2020 | Apr 15, 2025 |
| Türkiye | Apr 15, 2020 | Apr 15, 2025 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
+B862EYEON14WE0DBasic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
++B862EYEON14WED4EyeOn-14WEUDI 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.
Y214224AUGMENTATIVE SOFTWAREY214209ALPHABETIC AND SYMBOLIC COMMUNICATORSY214299DEVICES FOR INTERPERSONAL COMUNICATION - OTHERY214212VOICE GENERATORSNo certificate specifically references this device's Basic UDI-DI.
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.