- Role
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- Date of registration
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SE-MF-000002125Leksell Vantage X-Ray Fiducial Box is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by Elekta Solutions AB. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Jun 24, 2026
073402015BUDI000000019PSPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)07340201503676
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.
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 Netherlands; available across 32 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Cyprus | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Estonia | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Ireland | — | Still on market |
| Iceland | — | Still on market |
| Italy | — | Still on market |
| Liechtenstein | — | Still on market |
| Lithuania | — | Still on market |
| Luxembourg | — | Still on market |
| Latvia | — | Still on market |
| Malta | — | Still on market |
| Norway | — | Still on market |
| Poland | — | Still on market |
| Portugal | — | Still on market |
| Romania | — | Still on market |
| Sweden | — | Still on market |
| Slovenia | — | Still on market |
| Slovakia | — | Still on market |
| Türkiye | — | Still on market |
| XI | — | 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.
07340201503676Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
073402015BUDI000000019PS1136431UDI 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.
1 packaging level registered — each level carries its own UDI-DI.
07340201503676× 1 unitBase unit07340201503683× 1 unitEuropean Medical Device Nomenclature — the EU product classification assigned to this device.
Z12100601STEREOTACTIC NEUROSURGERY SYSTEMSNo certificate specifically references this device's Basic UDI-DI.
073400483BUDI000000002ZSOn the marketKaiku Health073402015BUDI000000001P7On the marketLeksell GammaPlan 11.5073400483BUDI000000001ZQOn the marketLeksell Vantage X-Ray Table Fixation073402015BUDI000000019PSOn the marketLeksell Vantage X-Ray Universal Fixation073402015BUDI000000019PSOn the marketMonaco RTP System00858164002BUDI0000002H9On the marketNo 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.