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EUDAMED last updated this device on Jul 26, 2026
7290015461Ex2100V1T3-PPU5Exablate 2100V1 Prostate Treatment Kit is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by InSightec Ltd.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
07290019402527SET001731-CE(01)07290019402527
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z120610ULTRASOUND THERAPY EQUIPMENT1 warning recorded — scroll inside the panel to see all entries.
Refer to instruction manual/ booklet
IL-MF-000011795The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Nov 16, 2021 | 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.
3902589CE01ReissuedNotified 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.
3902589CE01ReissuedNotified 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.
7290015461WatrKitSET841KKOn the marketDegassed Water 1L Pouch7290015461WpouchASM1480JEOn the marketExablate 2100V17290015461Ex2100V1T3SYS32On the marketExablate 40007290015461Ex4000-SYSFBOn the marketExablate 40007290015461Ex4000-SYSFBOn the marketExablate 4000 Patient Treatment Kit7290015461Ex4000-PPTXOn the market