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ES-MF-0000047101434-MDD-322/2020DJA is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Osatu Sociedad Cooperativa. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 28, 2026
B-REANIBEX100MJPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-REANIBEX100MJ
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
2 warnings recorded — scroll inside the panel to see all entries.
Follow the instructions for use
The defibrillator can deliver up to 360 Joules of energy during shock delivery. When the shock is being discharged to the patient, do not touch the patient or the defibrillation pads. During defibrillation, make sure that different parts of the patient’s body do not come into contact (bare skin on the head and limbs) with conducting fluids such as gel, blood or saline solution or with metal objects such as the stretcher. These can cause undesirable branching of the defibrillation current
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 Spain; available across 18 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | Aug 1, 2021 | Still on market |
| Austria | Jan 1, 2024 | Still on market |
| Belgium | Jan 1, 2024 | Still on market |
| Czechia | Jan 1, 2024 | Still on market |
| Germany | Jan 1, 2024 | Still on market |
| EL | Dec 1, 2021 | Still on market |
| France | Dec 1, 2021 | Still on market |
| Croatia | Jan 1, 2024 | Still on market |
| Ireland | Dec 1, 2021 | Still on market |
| Italy | Aug 1, 2021 | Still on market |
| Netherlands | Jan 1, 2024 | Still on market |
| Norway | Dec 1, 2021 | Still on market |
| Poland | Dec 1, 2021 | Still on market |
| Portugal | Dec 1, 2021 | Still on market |
| Romania | Jan 1, 2024 | Still on market |
| Sweden | Aug 1, 2021 | Still on market |
| Slovenia | Jan 1, 2024 | Still on market |
| Slovakia | Jan 1, 2024 | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-REANIBEX100MJBasic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-REANIBEX100MJDJAUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12030503AUTOMATIC DEFIBRILLATORSZ12030501SEMI-AUTOMATIC DEFIBRILLATORSCertificate health across this manufacturer's portfolio.
1000291268Supplemented1000291267SupplementedNotified 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 →No certificate specifically references this device's Basic UDI-DI.