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EUDAMED last updated this device on Nov 5, 2022
B-05065011188104COMBAT PRS+HIPEC SYSTEM is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Biosurgical S.L. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05065011188104COMPRS03(01)05065011188104
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z1204021501MULTI-DISTRICT ONCOLOGICAL HYPERTHERMIA EQUIPMENT5 warnings recorded — scroll inside the panel to see all entries.
Danger of electric shock. Do not open the system
To avoid the risk of electric shock, this system should only be connected to a power supply grid with grounding protection
Use exclusively with PRS disposable kits and accessories. The use of any other disposable kits or accessories could damage the equipment, and/or harm the patient.
Electrical Risk Classification
This device is sensible to proximity of electromagnetic fields according to rule IECE6061-1-2. Components are protected by the device cases and at a minimum distance of 15 cm as exception applied.
ES-MF-000008631ES19/86853Primary placement in Spain; available across 5 countries total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
| Italy | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Türkiye | — | 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 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.No certificate specifically references this device's Basic UDI-DI.