- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 10, 2026
5712368CM_SelDiffA2Chrom StrepB/SDA agarplade is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by SSI Diagnostica A/S. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
05712368000213213432(01)05712368000213
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0104010402CHROMOGENIC ID MEDIA (PLATES)Primary placement in Denmark; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Jun 10, 2026 | Still on market |
DK-MF-000023933The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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.
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 →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 →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.
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.
Certificate health across this manufacturer's portfolio.
V13 133113 0001IssuedNotified 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 →5712368CM_SelDiffA2On the marketChrom StrepB agarplade5712368CM_SelDiffA2On the marketChrom StrepB agarplade5712368CM_SelDiffA2On the marketChrom StrepB/SDA agarplade5712368CM_SelDiffA2On the marketChrom StrepB/StaphA agarplade5712368CM_SelDiffA2On the marketChrom StrepB/StaphA agarplade5712368CM_SelDiffA2On the market