- Role
- Country
- Date of registration
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EUDAMED last updated this device on Sep 4, 2023
5051700IK820GWEXENT® HCCA MALDI Matrix Pack is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by The Binding Site Group Ltd. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
UK-MF-000036707(01)05051700020664
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
6 warnings 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.
Primary placement in Germany; available across 6 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | — | Still on market |
| Belgium | — | Still on market |
| Spain | — | Still on market |
| France | — | Still on market |
| Italy | — | Still on market |
| Netherlands | — | 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.
05051700020664Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
5051700IK820GWIK820UDI 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.
W0201020185AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLESPrimary 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.5051700IK876HROn the marketEXENT® Disposable MALDI Plate Pack5051700IK819HDOn the marketEXENT® Elution Buffer 15051700IK877HTOn the marketEXENT® Immunoglobulin Isotypes (GAM) Control Pack5051700MSR801.MJ4On the marketEXENT® Mass Calibration Standard 15051700MSS801.MJHOn the marketEXENT® Wash Solution 15051700IK822H2On the marketNo certificate specifically references this device's Basic UDI-DI.