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EUDAMED last updated this device on Feb 17, 2026
80232790000M900100CC000UBGHIACCIO ISTANTANEO IN BUSTA PE is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIa. Manufactured by GIMA SPA. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
0802327934111934111(01)08023279341119
European Medical Device Nomenclature — the EU product classification assigned to this device.
M9001CRYOTHERAPY AND THERMOTHERAPY DEVICES4 warnings recorded — scroll inside the panel to see all entries.
not intended to come into direct contact with the skin: use with a cloth in between
IT-MF-000011004IT349382The 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 |
| Luxembourg | — | Still on market |
| Malta | — | 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 →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 →8023279L0104019900000007ZOn the marketFORBICINE IRIS DELICAT curve - 11 cm8023279L0104019900000007ZOn the marketFORBICINE IRIS DELICAT rette - 11 cm8023279L0104019900000007ZOn the marketGRANDE RIUNITO PARKER - nero802327900Z121402000000093On the marketGRANDE RIUNITO PARKER LARGE - nero802327900Z121402000000093On the marketI.V. STAND ON 5 WHEELA TROLLEY - stainless steel - 4 s/s hooks80232790000V90994500000C3On the market