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DE-MF-000005329SPO2 Soft-tip Sensor, Adult is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Drägerwerk AG & Co. KGaA. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 29, 2026
040486751308060XK19L010DAPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04048675379409
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning 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 | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | 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.
04048675379409Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
040486751308060XK19L010DA2606485UDI 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.
Z1203020480GASEOUS EXCHANGE MONITORING INSTRUMENTS - HARDWARE ACCESSORIES040486751301011XK19P01029On the marketSPO2 Extension Cable, 2m0404867511080606K19Z000RVOn the marketSPO2 finger sensor, 2.5 m040486751308060XK19Z000G9On the marketSPO2 soft-tip sensor, pediatric pat.040486751308060XK19L010DAOn the marketSpu GP Temp Probe Adult 1.6m0404867512080246K19Z000SGOn the marketSpu GP Temp Probe Adult 3.0m0404867512080246K19Z000SGOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
G10 010578 0039SupplementedNotified 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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