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EUDAMED last updated this device on Mar 26, 2026
8427860URO2100000021ABMFresenius Kabi is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by OIARSO, S. COOP. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08427860380226380.22(01)08427860380226
European Medical Device Nomenclature — the EU product classification assigned to this device.
A03040201BLADDER IRRIGATION KITS, SINGLE-USE1 warning recorded — scroll inside the panel to see all entries.
CW999Primary placement in France; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | Jun 27, 2025 | Still on market |
ES-MF-000000866The 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.
2023 PR 0007IssuedNotified 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 →8427860PAR2100000021AJHOn the marketBexen Medical8427860ENT2100000021ANPOn the marketFresenius Kabi8427860URO2100000021ABMOn the marketFRESENIUS KABIB-ESMF00000086638023E9On the marketKiro Oncology / Bexen Medical8427860REC2100000021A8YOn the marketMEDIPACB-ESMF00000086642301125PJOn the marketNo certificate specifically references this device's Basic UDI-DI.