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EUDAMED last updated this device on Jun 15, 2026
B-07332414126025PrisMax is an MDD-legacy medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Baxter Healthcare SA. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
07332414126025955725(01)07332414126025
European Medical Device Nomenclature — the EU product classification assigned to this device.
Z12090301HAEMOFILTRATION EQUIPMENT2 warnings recorded — scroll inside the panel to see all entries.
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
CH-MF-000026124G1 062680 0134Sterile
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.
00854120000000000000078JPOn the marketPress-In-Bottle-Adapter00854120000000000000078JPOn the marketPress-In-Bottle-Adapter00854120000000000000078JPOn the marketRAPIDFILL00854120000000000000003HQOn the marketSTERILE WATER FOR IRRIG (PLASTIC BOTTLE)0085412GMN000000000021474On the marketSTERILE WATER FOR IRRIG (PLASTIC BOTTLE)0085412GMN000000000004575On the marketCertificate health across this manufacturer's portfolio.
G10 056740 0065IssuedNotified 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.
G10 056740 0072IssuedNotified 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.
G10 056740 0047IssuedNotified 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.
G10 056740 0071IssuedNotified 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.
G10 056740 0057IssuedNotified 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.
G10 056740 0037IssuedNotified 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 →