- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Oct 25, 2024
594067440SUSCEPT.DISCSZKDiscs for antimicrobial susceptibility testing Oxacillin, OX, 1mcg is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Tody Laboratories Med SRL. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
RO-MF-000037201(01)05940674401800
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
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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 Spain; available across 1 country total.
Placed on the market in Spain; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
05940674401800Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
594067440SUSCEPT.DISCSZKC39SD1139UDI 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.
W0104080502IMPREGNATED DISKS, MULTI-DISKS & TABLETSPrimary 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.
594067440SUSCEPT.DISCSZKOn the marketDiscs for antimicrobial susceptibility testing Norfloxacin, NX, 10mcg594067440SUSCEPT.DISCSZKOn the marketDiscs for antimicrobial susceptibility testing Ofloxacin, OF, 5mcg594067440SUSCEPT.DISCSZKOn the marketDiscs for antimicrobial susceptibility testing Oxacilln, OX, 5mcg594067440SUSCEPT.DISCSZKOn the marketDiscs for antimicrobial susceptibility testing Pefloxacin, PF, 5mcg594067440SUSCEPT.DISCSZKOn the marketDiscs for antimicrobial susceptibility testing Penicillin, P, 10mcg594067440SUSCEPT.DISCSZKOn the marketNo 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.