- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 21, 2024
B-50002_a3ACortrium Apex is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Cortrium ApS. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
DK-MF-000007827G1 098327 0004D-50002_a3A
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 Denmark; available across 13 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Oct 1, 2020 | Still on market |
| Austria | Nov 1, 2019 | Still on market |
| Germany | Oct 1, 2020 | Still on market |
| Estonia | Oct 1, 2020 | Still on market |
| Finland | Oct 1, 2020 | Still on market |
| France | May 26, 2021 | Still on market |
| Hungary | Sep 28, 2021 | Still on market |
| Italy | Oct 21, 2020 | Still on market |
| Lithuania | Oct 1, 2020 | Still on market |
| Latvia | Nov 4, 2020 | Still on market |
| Poland | Jul 1, 2020 | Still on market |
| Portugal | Dec 15, 2021 | Still on market |
| Sweden | Oct 1, 2022 | 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.
D-50002_a3ABasic 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-50002_a3A50002_aUDI 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.
Z12050392ELECTROCARDIOGRAPHS - MEDICAL DEVICE SOFTWAREPrimary 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.
Certificate health across this manufacturer's portfolio.
G10 098327 0006IssuedNotified 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.
View in glossary →