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EUDAMED last updated this device on Jun 14, 2023
B-10402EHeCO2 Plus is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Lutronic Corporation. Placed on the EU market in Bulgaria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-10402EHeCO2 PlusKR-MF-0000090359744-2017-CE-KOR-NA-PSD-10402EH
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA 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 Bulgaria; available across 13 countries total.
| Country | On market since | Until |
|---|---|---|
| BulgariaPrimary placement | May 13, 2021 | Dec 31, 2029 |
| Austria | Aug 18, 2022 | Dec 31, 2029 |
| Cyprus | Aug 30, 2021 | Dec 31, 2029 |
| Czechia | Nov 17, 2021 | Dec 31, 2029 |
| Germany | Jun 30, 2021 | Dec 31, 2029 |
| Finland | Aug 19, 2022 | Dec 31, 2029 |
| France | Oct 26, 2021 | Dec 31, 2029 |
| Hungary | Jan 25, 2022 | Dec 31, 2029 |
| Italy | Mar 15, 2022 | Dec 31, 2029 |
| Latvia | Nov 28, 2022 | Dec 31, 2029 |
| Poland | May 31, 2021 | Dec 31, 2029 |
| Romania | Oct 29, 2021 | Dec 31, 2029 |
| Sweden | Feb 2, 2023 | Dec 31, 2029 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12011005CARBON DIOXIDE SURGICAL LASERPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →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.
Certificate health across this manufacturer's portfolio.
2975-MED-2601901IssuedC555614CancelledNotified 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 →Notified 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 →