- Role
- Country
- Date of registration
- Address
RO-MF-000010877Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 26, 2026
5944759080VTSTA25STSMB6Y7Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)05944759080096
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.
05944759080096Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
5944759080VTSTA25STSMB6Y7VT-STA-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.
W0105090103STREP. A - RT & POCNo 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.No certificate specifically references this device's Basic UDI-DI.
5944759080VTHPB25SPROB6HCOn the marketMulti-Line 12 Drugs Rapid Test Cassette (urine) TEST RAPID MULTIDROG 12 PARAMETRI (DIN URINA) CASETA5944759080VTMLD1225USB6V3On the marketMulti-Line 18 Drugs (urine) Test Cassette TEST RAPID MULTIDROG 18 PARAMETRI (DIN URINA) CASETA5944759080VTMLD1825USB6Y9On the marketRotavirus Ag and Adenovirus Ag (Feces) COMBO Rapid Test Cassette Test rapid Rotavirus Ag si Adenovirus Ag (materii fecale) COMBO caseta5944759080VTRACG25FECB64HOn the marketRSV Ag + Adenovirus Resp. Ag COMBO rapid test cassette (Swab) positive controls included Test rapid determinare RSV Ag + Adenovirus Resp. Ag COMBO, caseta (Swab) cu controale pozitive incluse5944759080VTRSVA25STNB68GOn the marketSyphilis (Whole blood /Serum /Plasma) Rapid Test Cassette Test rapid Sifilis (sange total/ser/plasma) caseta5944759080VTSYP25WBSPC3BEOn the market