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DE-MF-000006028LEONI 4 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Löwenstein Medical SE & 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 15, 2026
426055656Leoni4ZBPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04260556560038
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
4 warnings recorded — scroll inside the panel to see all entries.
SPO2 sensor application part of type BF
Service flap - Attention
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 15 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Denmark | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Luxembourg | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Türkiye | — | 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.
04260556560038Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
426055656Leoni4ZB0730000UDI 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.
Z1203010503NEONATAL/PAEDIATRIC PULMONARY VENTILATORSNo certificate specifically references this device's Basic UDI-DI.
426017127NeoJetRMOn the marketleon plus426017127LeonPlus6ROn the marketleon plus Wand426017127LeonPlus6ROn the marketLM Neonatal Testlung, Disposable426017127TestlungL8On the marketLM Neonatal Testlung, Reusable426017127TestlungL8On the marketSingle use expiratory valve set426017127NeoExpValveM8On the marketCertificate health across this manufacturer's portfolio.
HZ 1011391-1IssuedNotified 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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