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IT-MF-000025691Catetere di Urodinamica monolume per il rilevamento della Pressione Addominale con Introduttore. Palloncino in polisoprene 7 x 20 mm is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by Medica S.p.A.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jul 15, 2026
803377232CAT-U0504MNPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08033772327619
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
6 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 Italy; available across 9 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Jun 1, 2023 | Still on market |
| Austria | Jun 1, 2023 | Still on market |
| Germany | Jun 1, 2023 | Still on market |
| Spain | Jun 1, 2023 | Still on market |
| France | Jun 1, 2023 | Still on market |
| Ireland | Jun 1, 2023 | Still on market |
| Netherlands | Jun 1, 2023 | Still on market |
| Portugal | Jun 1, 2023 | Still on market |
| XI | Jun 1, 2023 | 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.
08033772327619Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
803377232CAT-U0504MN1AR-5I UDI 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.
2 packaging levels registered — each level carries its own UDI-DI.
08033772327619× 1 unitBase unit18033772327616× 10 units28033772327613× 50 unitsEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
U050402INTRA-ABDOMINAL PRESSURE MEASUREMENT CATHETERS, WITH BALLOON803377232CAT-U0502MJOn the marketCatetere a 9 vie per manometria anorettale / 9-ways catheter for anorectal manometry803377232CAT-G0206GHOn the marketCatetere a 9 vie per manometria del colon / 9-ways colon Manometry Catheter803377232CAT-G0206GHOn the marketCatetere manometria anorettale 12 canali con pallone / Anorectal manometry catheter with radial 12 channels with balloon803377232CAT-G0206GHOn the marketCatetere manometria anorettale 4 canali elicoidali ad 1 cm e palloncino a -1 cm / Anorectal manometry catheter 4 helicoidal channels at 1 cm and balloon at -1 cm803377232CAT-G0206GHOn the marketCatetere manometria anorettale 4 canali elicoidali ad 1 cm e palloncino a -3 cm / Anorectal manometry catheter 4 helicoidal channels at 1 cm and balloon at -3 cm803377232CAT-G0206GHOn the marketNo 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.No certificate specifically references this device's Basic UDI-DI.