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EUDAMED last updated this device on Mar 31, 2026
805620966DBMWATERFLUSHDBD.B.M. AQUAFLUSH is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by DBM SRL. Placed on the EU market in Ireland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
38056209661644PCG01MB1TG(01)38056209661644
European Medical Device Nomenclature — the EU product classification assigned to this device.
A02010702PREFILLED SYRINGES WITH STERILE WATER1 warning recorded — scroll inside the panel to see all entries.
PRECAUTIONS • Do not use the product for purposes other than its intended use. • Do not use the product if the packaging is open or damaged, if the syringe is not fully intact or if the cap is damaged in such a way as to cause leakage from the syringe. • Do not use the product if the solution is not colourless or contains visible particulate matter. • Once opened, the device must be used immediately and disposed of after use. • For single use only. Dispose of any partially used product, the reuse of which could cause cross contamination between patient and operator. • Do not resterilise. Resterilisation carries a risk of cross infection for the patient and/or user. • Do not draw air into the syringe and do not allow air to be trapped in the fluid path. • Use only with compatible Luer adapters.
Primary placement in Ireland; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| IrelandPrimary placement | Mar 20, 2026 | Still on market |
IT-MF-000017565The 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 →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 →