- Organization name
- UDI-DI code
- Reference / catalog number
MX-MF-0000138275-859-200-1812P-E17T00 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Oculus Technologies of México S.A. de C.V.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Dec 14, 2021
B-07503006698996Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)07503006698996
4 warnings recorded — scroll inside the panel to see all entries.
If tamper resistant seal is broken or missing, do not use
Keep out of the reach and out of sight of children
After use the container should be closed again, before storing
OTHER
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 22 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Dec 12, 2013 | Dec 30, 2028 |
| Bulgaria | Dec 12, 2013 | Dec 30, 2028 |
| Czechia | Dec 12, 2013 | Dec 30, 2028 |
| Germany | Dec 12, 2013 | Dec 30, 2028 |
| Denmark | Dec 12, 2013 | Dec 30, 2028 |
| Estonia | Dec 12, 2013 | Dec 30, 2028 |
| EL | Dec 12, 2013 | Dec 30, 2028 |
| Spain | Dec 12, 2013 | Dec 30, 2028 |
| Finland | Dec 12, 2013 | Dec 30, 2028 |
| France | Dec 12, 2013 | Dec 30, 2028 |
| Croatia | Dec 12, 2013 | Dec 30, 2028 |
| Hungary | Dec 12, 2013 | Dec 30, 2028 |
| Iceland | Dec 12, 2013 | Dec 30, 2028 |
| Italy | Dec 12, 2013 | Dec 30, 2028 |
| Lithuania | Dec 12, 2013 | Dec 30, 2028 |
| Latvia | Dec 12, 2013 | Dec 30, 2028 |
| Norway | Dec 12, 2013 | Dec 30, 2028 |
| Poland | Dec 12, 2013 | Dec 30, 2028 |
| Portugal | Dec 12, 2013 | Dec 30, 2028 |
| Sweden | Dec 12, 2013 | Dec 30, 2028 |
| Slovenia | Dec 12, 2013 | Dec 30, 2028 |
| Slovakia | Dec 12, 2013 | Dec 30, 2028 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
07503006698996Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-07503006698996P-E17T00UDI 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.
D0399CHLORINE DERIVATIVES FOR THE DISINFECTION OF MEDICAL DEVICES - OTHERNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
2024 CR 0031IssuedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
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