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EUDAMED last updated this device on Oct 7, 2022
805415466_DDS/FIX_K7DDS/FIX is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by FONDAZIONE CENTRO NAZIONALE DI ADROTERAPIA ONCOLOGICA. Placed on the EU market in Austria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08054154660018DDS/FIX(01)08054154660018
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11019099VARIOUS RADIOTHERAPY AND RADIOSURGERY INSTRUMENTS - OTHERPrimary placement in Austria; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| AustriaPrimary placement | Feb 29, 2016 | Still on market |
IT-MF-000021295CVP0001220225CVP0002220225CVP0003220225CVP0004220225CVT000122The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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 →CVP0004220225AmendedCVP0003220225AmendedCVP0001220225AmendedCVP0002220225AmendedCVT000122AmendedCertificate health across this manufacturer's portfolio.
CVP0005220225AmendedNotified 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.
CVP0004220225AmendedNotified 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.
CVP0003220225AmendedNotified 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.
CVP0001220225AmendedNotified 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.
CVP0006230225AmendedNotified 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.
CVP0002220225AmendedNotified 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 →