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EUDAMED last updated this device on Nov 12, 2024
B-ITMF000017565PCG06NA1FLD.B.M. SALINEFLUSH is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by DBM SRL. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-ITMF000017565PCG06NA1FLPCG06NA1IT-MF-000017565MED 31220D-ITMF000017565PCG06NA1FL
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
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 9 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Oct 31, 2016 | Still on market |
| Austria | Sep 10, 2020 | Still on market |
| Bulgaria | Nov 30, 2023 | Still on market |
| Germany | Feb 25, 2019 | Still on market |
| EL | Mar 11, 2019 | Still on market |
| France | Nov 15, 2017 | Still on market |
| Ireland | Jun 21, 2019 | Still on market |
| Sweden | Mar 11, 2021 | Sep 1, 2024 |
| Slovenia | Mar 4, 2020 | Jan 1, 2024 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
C0180ARTERO-VENOUS SYSTEM DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSESPrimary 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 →No certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
0425-MDR-030159-00Issued0425-MDR-030158-00Issued0425-MDR-030079-00IssuedNotified 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 →