- Organization name
- UDI-DI code
- Reference / catalog number
RO-MF-000010877Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (Feces), positive controls included Test rapid determinare Clostridium difficile GDH+Toxina A+Toxina B, caseta COMBO (materii fecale) cu controale pozitive swab incluse is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 26, 2026
5944759080VTCDABGDH25B6X8Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05944759080126
The 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.
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 Romania; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary placement | May 26, 2026 | Dec 31, 2030 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
05944759080126Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
5944759080VTCDABGDH25B6X8VT-CDABGDH-25UDI 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.
W0105011803C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTIONNo 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.5944759080VTENTG25FECB6FWOn the marketFOB RAPID TEST CASSETTE (FECES), POSITIVE CONTROL SWAB INCLUDED5944759080VTFOB25FECPB62BOn the marketGiardia lamblia Ag (Feces)Rapid Test cassette Test rapid Giardia lamblia Ag (din materii fecale) caseta5944759080VTGIAG25FECB6XKOn the market