- Role
- Country
- Date of registration
- Address
US-MF-000007934No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.Nebulizer is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Salter Labs. 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 9, 2026
0607411TF20013d_NebEEPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)10607411890069
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
2 warnings recorded — scroll inside the panel to see all entries.
Do not attempt to sterilize or autoclave this device. The measurement accuracy, system performance, or a malfunction may occur as a result of the product being physically damaged due to disinfection and/or re-sterilization.
This is a single-patient multi-use product, reuse on more than one patient may cause a risk of cross-contamination.
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 21 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Cyprus | — | Still on market |
| Denmark | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Luxembourg | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Sweden | — | 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.
10607411890069Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
0607411TF20013d_NebEE8901-0-50UDI 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.
R060101COLD NEBULISATION SYSTEMS0607411TF20017a_O2CannLLOn the marketNasal Micro Cannula (Adult) Salter Style, 4’ (1.2 m) 0‐3 LPM supply tube0607411TF20017a_O2CannLLOn the marketNasal Micro Cannula (Adult) Salter Style, 7’ (2.1 m) 0‐3 LPM supply tube0607411TF20017a_O2CannLLOn the marketNebulizer Kit, mouthpiece, T-adaptor, reservoir, 7’ (2.1 m) supply tube, female thread grip connector.0607411TF20013d_NebEEOn the marketNebulizer Set, mouthpiece, T-adaptor0607411TF20013d_NebEEOn the marketNebulizer Set, mouthpiece, T-adaptor, 7’ (2.1 m) supply tube0607411TF20013d_NebEEOn the marketNo certificate specifically references this device's Basic UDI-DI.