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IT-MF-000026962MED 9827-ATRUE FLOW RDB CLOSE TIP is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by MED EUROPE EUROPEAN MEDICAL SUPPLIES SRL. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jan 8, 2026
B-08033609524297Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08033609524297
5 warnings recorded — scroll inside the panel to see all entries.
L’uso di questo dispositivo è controindicato nei pazienti con accertata ipersensibilità al silicone; il prodotto deve essere utilizzato immediatamente dopo l’apertura della confezione; una volta aperta la confezione, esaminare il prodotto attentamente: non utilizzarlo in caso si riscontrino difetti; danni involontari al corpo della cannula causati da lame o aghi possono ridurre notevolmente la forza tensile del dispositivo. Prestare quindi molta attenzione durante l’inserimento, l’utilizzo e la rimozione. Se una cannula viene involontariamente perforata evitarne l’utilizzo. La cannula deve essere posizionata e rimossa manualmente (l’uso di strumenti può causarne la rottura), con pressione leggera e costante. Non gonfiare eccessivamente il palloncino. Pressione massima di utilizzo non superiore a 150 mmHg. Non tentare di inserire la cannula con il palloncino gonfio. Non tentare di rimuovere la cannula se il palloncino è gonfio.
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 Italy; available across 12 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| Hungary | — | Still on market |
| Luxembourg | — | Still on market |
| Netherlands | — | Still on market |
| Portugal | — | Still on market |
| Slovakia | — | 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.
08033609524297Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-08033609524297RDB-0CSUDI 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.
C03010405SELECTIVE CAROTID ARTERY AND CORONARY SINUS PERFUSION CANNULASNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
ITI 2522914 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.
ITH 2522914 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.
ITH 2522914 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.
0425-MDR-030102-01AmendedNotified 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.
0425-MDR-030028-02IssuedNotified 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.
0425-MDR-030029-02IssuedNotified 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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