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EUDAMED last updated this device on Dec 22, 2025
803360952NSCSE9NEW SAFETY COUNT SYSTEM is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. 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.
08033609523740NPRSC 006S(01)08033609523740
European Medical Device Nomenclature — the EU product classification assigned to this device.
V9099VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER5 warnings recorded — scroll inside the panel to see all entries.
Non riempire oltre la capienza massima: tutte le lame e gli aghi devono essere posizionati correttamente in modo che siano fissati. In particolare, gli aghi devono essere sempre inseriti nel contenitore stesi, cioè paralleli alla superficie orizzontale. Nessun tagliente deve oltrepassare il limite fisico del dispositivo in modo da non ostacolare la chiusura dello stesso.
IT-MF-000026962The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Italy; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Ireland | — | Still on market |
| Sweden | — | Still on market |
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.
View in glossary →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.
View in glossary →Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
View in glossary →CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
View in glossary →Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →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.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →803360952NSCSE9On the marketNEW SAFETY COUNT SYSTEM803360952NSCSE9On the marketNEW SAFETY COUNT SYSTEM803360952NSCSE9On the marketNEW SAFETY COUNT SYSTEM803360952NSCSE9On the marketNEW SAFETY COUNT SYSTEM803360952NSCSE9On the marketNEW SAFETY COUNT SYSTEM803360952NSCSE9On the marketNo 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.
View in glossary →