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EUDAMED last updated this device on Jun 28, 2022
B-08428097930901ihtEvolve 4.0(SC)/4,5(NC)x10mm is an MDD-legacy medical device registered in EUDAMED. It is classified as Class III. Manufactured by Iberhospitex, S.A.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
084280979309010067402(01)08428097930901
European Medical Device Nomenclature — the EU product classification assigned to this device.
C010401020101PTCA BALLOON DILATION CATHETERS5 warnings recorded — scroll inside the panel to see all entries.
Primary placement in Spain; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Jun 29, 2020 | Still on market |
| Croatia | Sep 30, 2020 | Still on market |
ES-MF-000000160ES19-86944ES20-87274Sterile
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 →B-08428097930604On the marketihtEvolve 3.5(SC)/4(NC)x30mmB-08428097930703On the marketihtEvolve 3.5(SC)/4(NC)x6mmB-08428097930208On the marketihtEvolve 4.0(SC)/4,5(NC)x15mmB-08428097931007On the marketihtEvolve 4.0(SC)/4,5(NC)x6mmB-08428097930802On the marketOper cat 16 x 5 cm8428097CATHBOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
2025 CR 0045Supplemented2024 PR 0030IssuedES22/00000630AmendedNotified 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 →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 →