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IT-MF-000041134MATERASSO NOVAPURE PRO FRESH is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by MITA 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 Jun 4, 2026
805848147NOPB25CTVPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08058481473044
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.
CW010Sterile
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 17 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Malta | — | Still on market |
| Poland | — | Still on market |
| Romania | — | 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.
08058481473044Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
805848147NOPB25CTVNOPB25CUDI 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.
V080702NON ACTIVE ANTI-DECUBITUS MEDICAL MATTRESSESNo certificate specifically references this device's Basic UDI-DI.
805848147MRYBFMVOn the marketMATERASSO NARDIK805848147NARB25LPFOn the marketMATERASSO NOVAPURE PRO EASY CLEAN805848147NOPB25ETZOn the marketMATERASSO NOVAPURE PRO NATURFEEL805848147NOPB25KUDOn the marketMATERASSO NOVAPURE PRO TEX805848147NOPB25HU7On the marketMATERASSO NOVAPURE PRO THERMOBALANCE805848147NOPB25BTTOn 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.