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EUDAMED last updated this device on Feb 25, 2026
B-5000A2XiScan 5000 is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by MIZAR HEALTH, S.L.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-5000A25000D-5000A2
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z11039009FLUOROSCOPY DEVICES4 warnings recorded — scroll inside the panel to see all entries.
Las radiaciones ionizantes son potencialmente peligrosas. Deben utilizarse todos los medios de radioprotección disponibles durante el uso del equipo, y deben tomarse precauciones especiales o medidas preventivas adicionales en los siguientes casos: • Debe procurarse una especial protección del embrión o feto en los exámenes o tratamientos de mujeres embarazadas. • Los órganos sensibles del cuerpo (p.ej., cristalino de ojos o gónadas) deben estar completamente protegidos siempre que puedan quedar expuestos al haz activo. Se debe utilizar el equipo junto a elementos de protección individual para radiaciones ionizantes, un delantal emplomado, un protector tiroideo y el dosímetro personal. Este último debe estar colocado debajo del delantal emplomado y nunca encima del mismo. Se debe utilizar adecuadamente el dosímetro, efectúe mensualmente el cambio del mismo, y no debe exponerse voluntariamente a radiaciones.
Se debe evite la manipulación forzada de cables y conectores. Se debe controlar que el equipo está funcionando conectado a la red eléctrica y sólo se alimenta a través del SAI en momentos puntuales (traslado, corte de suministro eléctrico, etc.). El uso inadecuado del SAI produce la descarga total de las baterías y el equipo no arrancará.
ES-MF-0000145422001 01 0301 CTPrimary placement in Spain; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
| France | — | Still on market |
| Italy | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
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 →No certificate specifically references this device's Basic UDI-DI.
No certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.