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SG-MF-000023910QTRAP 4500MD MS/MS System is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by AB SCIEX Pte. Ltd. Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Dec 15, 2025
084236514500MDP3Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)00842365102063
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
8 warnings recorded — scroll inside the panel to see all entries.
DANGER! Explosion Hazard. Do not operate the system in an environment containing explosive gases. The system is not designed for operation in an explosive environment
WARNING! Environmental Hazard. Follow established procedures for disposal of biohazardous, toxic, radioactive, and electronic waste. The customer is responsible for disposal of hazardous substances, including chemicals, waste oils, and electrical components, in accordance with local laws and regulations.
WARNING! Hot Surface Hazard. Let the Turbo V ion source cool for at least 30 minutes before starting any maintenance procedures. Some surfaces of the ion source and vacuum interface become hot during operation.
WARNING! Lifting Hazard. Use a mechanical lifting device to lift and move the mass spectrometer. If the mass spectrometer must be moved manually, then at least six people are required to move it safely. Follow established safe lifting procedures. We recommend the use of a professional moving service. For the weights of system components, refer to the document: Site Planning Guide.
WARNING! Fire Hazard. Make sure that the source exhaust system is connected and functioning, to prevent flammable vapor from accumulating in the ion source.
WARNING! Ionizing Radiation Hazard, Biohazard, or Toxic Chemical Hazard. Do not operate the mass spectrometer if the source exhaust drain and roughing pump exhaust hoses are not properly connected to the laboratory ventilation system. Examine the exhaust tubing regularly to make sure that there are no leaks. The use of mass spectrometers without proper system ventilation might constitute a health hazard and might result in serious injury.
WARNING! Puncture Hazard, Ionizing Radiation Hazard, Biohazard, or Toxic Chemical Hazard. Discontinue use of the ion source if the ion source window is cracked or broken, and then contact a SCIEX Field Service Employee (FSE). Any toxic or injurious materials introduced in the equipment will be present in the source exhaust output. Exhaust from equipment should be vented from the room. Dispose of sharps following established laboratory safety procedures.
WARNING! Electrical Shock Hazard. Do not remove the covers. Removing the covers might cause injury or malfunctioning of the system. The covers need not be removed for routine maintenance, inspection, or adjustment. Contact a SCIEX Field Service Employee (FSE) for repairs that require the covers to be removed.
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.
Primary placement in Netherlands; available across 14 countries total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary placement | — | Still on market |
| Austria | — | Still on market |
| Belgium | — | Still on market |
| Bulgaria | — | Still on market |
| Germany | — | Still on market |
| Denmark | — | Still on market |
| Spain | — | Still on market |
| Finland | — | Still on market |
| France | — | Still on market |
| Ireland | — | Still on market |
| Italy | — | Still on market |
| Luxembourg | — | Still on market |
| Poland | — | Still on market |
| Slovenia | — | 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.
00842365102063Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
084236514500MDP35061722UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W020303MASS - SPECTROMETRY SYSTEMNo 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.