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EUDAMED last updated this device on May 14, 2026
805005413TC55401RQGRAM – KIT CON SAFRANINA sec. Hucker is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Titolchimica S.p.A.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
08050054131092TC55401(01)08050054131092
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0104080203GRAM POSITIVE - MANUAL IDENTIFICATIONW0104080201GRAM NEGATIVE - MANUAL IDENTIFICATIONIT-MF-000028986No 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.The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
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.
805005413TC56200RKOn the marketGIEMSA REAGENTE805005413TC56200RKOn the marketGRAM - KIT PER COLORAZIONE SEC. NICOLLE805005413TC55400RNOn the marketGRAM FUCSINA BASICA805005413TC55500RTOn the marketGRAM FUCSINA BASICA805005413TC55500RTOn the marketGRAM LUGOL SOLUZIONE IODO-IODURATA805005413TC61300QYOn the market