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IT-MF-000011004MONOFILAMENTO 2 - VALUTATORE DI SENSIBILITÀ is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by GIMA SPA. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 28, 2026
802327900V0302078600000AFPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08023279312829
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.
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 |
| Cyprus | — | Still on market |
| Germany | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Malta | — | Still on market |
| Netherlands | — | Still on market |
| Portugal | — | Still on market |
| XI | — | 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.
08023279312829Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
802327900V0302078600000AF31282UDI 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.
V030207SENSITIVITY MEASUREMENTS DEVICES NOT INCLUDED IN OTHER CLASSES802327900Q0304997500000C9On the marketMINI SPECULUM MONOUSO diam. 4mm - neri802327900Q0304997500000C9On the marketMINI SPECULUM MONOUSO diam. 4mm - verdi802327900Q0304997500000C9On the marketNUOVA PIANTANA PER IPODERMOCLISI - portata 28 kg80232790000V90994500000C3On the marketOFTALMOSCOPIO F.O. SIGMA - 2,5V - LED8023279Z121201140000000Q9On the marketOFTALMOSCOPIO F.O. SIGMA - 2,5V - LED - in borsetta morbida8023279Z121201140000000Q9On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
IT349382IssuedIT349382IssuedNotified 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 →