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NL-MF-000001489StentBoost - 4 is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class IIb. Manufactured by Philips Medical Systems Nederland B.V.. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Oct 25, 2024
0884838BM317SSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00884838059269
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
CW018Sterile
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 Netherlands; available across 28 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | Apr 20, 2015 | Still on market |
| Austria | Apr 20, 2015 | Still on market |
| Belgium | Apr 20, 2015 | Still on market |
| Bulgaria | Apr 20, 2015 | Still on market |
| Cyprus | Apr 20, 2015 | Still on market |
| Czechia | Apr 20, 2015 | Still on market |
| Germany | Apr 20, 2015 | Still on market |
| Denmark | Apr 20, 2015 | Still on market |
| Estonia | Apr 20, 2015 | Still on market |
| EL | Apr 20, 2015 | Still on market |
| Spain | Apr 20, 2015 | Still on market |
| Finland | Apr 20, 2015 | Still on market |
| France | Apr 20, 2015 | Still on market |
| Croatia | Apr 20, 2015 | Still on market |
| Hungary | Apr 20, 2015 | Still on market |
| Ireland | Apr 20, 2015 | Still on market |
| Iceland | Apr 20, 2015 | Still on market |
| Italy | Apr 20, 2015 | Still on market |
| Lithuania | Apr 20, 2015 | Still on market |
| Luxembourg | Apr 20, 2015 | Still on market |
| Latvia | Apr 20, 2015 | Still on market |
| Norway | Apr 20, 2015 | Still on market |
| Poland | Apr 20, 2015 | Still on market |
| Portugal | Apr 20, 2015 | Still on market |
| Romania | Apr 20, 2015 | Still on market |
| Sweden | Apr 20, 2015 | Still on market |
| Slovenia | Apr 20, 2015 | Still on market |
| Slovakia | Apr 20, 2015 | 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.
00884838059269Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
0884838BM317SS001007UDI 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.
Z11030182DIGITAL ANGIOGRAPHY SYSTEMS - SOFTWARE ACCESSORIES0884838BM798U8On the marketStandard mattress for Azurion series 70884838BM798U8On the marketStandard mattress for Azurion series S0884838BM798U8On the marketStentBoost Live0884838BM324SPOn the marketTabletop extender0884838BM474TBOn the marketTrolley0884838BM474TBOn the marketCertificate health across this manufacturer's portfolio.
HZ 1135905-1SupplementedNotified 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.