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DE-MF-000016838elisa 500 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Löwenstein Medical Innovation GmbH & Co. KG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jan 23, 2026
426019209elisa300/500WMPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04260192090326
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
3 warnings recorded — scroll inside the panel to see all entries.
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 Germany; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Mar 22, 2018 | Still on market |
| Austria | Mar 22, 2018 | Still on market |
| Belgium | Mar 22, 2018 | Still on market |
| Bulgaria | Mar 19, 2020 | Still on market |
| Cyprus | Apr 18, 2019 | Still on market |
| Czechia | Sep 26, 2019 | Still on market |
| Denmark | Sep 20, 2019 | Still on market |
| Estonia | Mar 23, 2021 | Still on market |
| EL | Aug 25, 2020 | Still on market |
| Spain | Sep 17, 2019 | Still on market |
| Finland | Sep 30, 2019 | Still on market |
| France | Jun 3, 2019 | Still on market |
| Croatia | Apr 20, 2020 | Still on market |
| Hungary | Feb 16, 2021 | Still on market |
| Ireland | Apr 18, 2019 | Still on market |
| Iceland | Apr 18, 2019 | Still on market |
| Italy | May 27, 2019 | Still on market |
| Liechtenstein | Mar 22, 2018 | Still on market |
| Lithuania | May 11, 2023 | Still on market |
| Luxembourg | Mar 22, 2018 | Still on market |
| Latvia | Apr 15, 2024 | Still on market |
| Malta | Apr 18, 2019 | Still on market |
| Netherlands | Jun 25, 2019 | Still on market |
| Norway | Sep 20, 2019 | Still on market |
| Poland | Jun 13, 2019 | Still on market |
| Portugal | Sep 4, 2019 | Still on market |
| Romania | Dec 20, 2019 | Still on market |
| Sweden | Sep 17, 2019 | Still on market |
| Slovenia | Oct 22, 2019 | Still on market |
| Slovakia | Sep 16, 2019 | Still on market |
| Türkiye | Oct 23, 2019 | Still on market |
| XI | Apr 18, 2019 | 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.
04260192090326Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
426019209elisa300/500WMAG-480500UDI 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.
Z1203010504ADULT AND PAEDIATRIC/NEONATAL PULMONARY VENTILATORSNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
G10 012094 0035SupplementedNotified 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.