- Role
- Country
- Date of registration
- Address
DE-MF-000000201ProSet Intrafix® SafeSet is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by B. Braun Melsungen AG. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jul 9, 2026
403923900000026525Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)04045928009571
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
5 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 27 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Nov 2, 2004 | Still on market |
| Austria | Nov 2, 2004 | Still on market |
| Belgium | Nov 2, 2004 | Still on market |
| Bulgaria | Nov 2, 2004 | Still on market |
| Cyprus | Nov 2, 2004 | Still on market |
| Czechia | Nov 2, 2004 | Still on market |
| Denmark | Nov 2, 2004 | Still on market |
| Estonia | Nov 2, 2004 | Still on market |
| EL | Nov 2, 2004 | Still on market |
| Spain | Nov 2, 2004 | Still on market |
| Finland | Nov 2, 2004 | Still on market |
| France | Nov 2, 2004 | Still on market |
| Croatia | Nov 2, 2004 | Still on market |
| Hungary | Nov 2, 2004 | Still on market |
| Ireland | Nov 2, 2004 | Still on market |
| Italy | Nov 2, 2004 | Still on market |
| Lithuania | Nov 2, 2004 | Still on market |
| Luxembourg | Nov 2, 2004 | Still on market |
| Latvia | Nov 2, 2004 | Still on market |
| Malta | Nov 2, 2004 | Still on market |
| Netherlands | Nov 2, 2004 | Still on market |
| Poland | Nov 2, 2004 | Still on market |
| Portugal | Nov 2, 2004 | Still on market |
| Romania | Nov 2, 2004 | Still on market |
| Sweden | Nov 2, 2004 | Still on market |
| Slovenia | Nov 2, 2004 | Still on market |
| Slovakia | Nov 2, 2004 | 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.
04045928009571Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
4039239000000265254187890UDI 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.
1 packaging level registered — each level carries its own UDI-DI.
04045928009571× 1 unitBase unit04046963920159× 50 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
A03010101INFUSION CONTROLLERS WITH OR W/O AIR INLETCertificate health across this manufacturer's portfolio.
G15 012974 0679SupplementedG10 012974 0611SupplementedG12 012974 0638SupplementedG12 012974 0651SupplementedG11 012974 0626SupplementedNotified 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 →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 →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 →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 →40392390000007812UOn the marketProSet Intrafix® SafeSet40392390000007812UOn the marketProSet Intrafix® SafeSet40392390000007812UOn the marketProSet Intrafix® SafeSet40392390000007812UOn the marketProSet Intrafix® SafeSet40392390000007812UOn the marketProSet Intrafix® SafeSet40392390000007812UOn the marketNo certificate specifically references this device's Basic UDI-DI.