- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED data as of Jun 25, 2026
EUDAMED last updated this device on Jan 29, 2026
3661540PARhemag027EHYDATIDOSE is an EU IVDR-regulated in vitro diagnostic on the European market. It is classified as IVDR Class B. Manufactured by ELITECH MICROBIO. Placed on the EU market in France. Explore certificates, regulatory status and the official record on MD Atlas.
FR-MF-000025235(01)03661540101021
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
8 warnings recorded — scroll inside the panel to see all entries.
Tous les réactifs, sauf le réactif BUF, contiennent des substances d’origine animale et doivent être manipulés avec les précautions d’usage. Les prélèvements sont potentiellement infectieux. Ils doivent être manipulés avec les précautions d’usage en respectant les règles d’hygiène et la réglementation en vigueur dans le pays d’utilisation.
Les réactifs contiennent de l’azide de sodium (concentration < 0,1%). L'azide de sodium contenu dans les réactifs peut réagir avec les métaux lourds des canalisations pour former des composés explosifs. Il est donc recommandé de ne pas jeter les réactifs à l'évier et de suivre les recommandations et réglementations d'élimination des déchets en vigueur.
OTHER
OTHER
Ne pas utiliser les réactifs au-delà de la date de péremption.
Ne pas utiliser les réactifs endommagés ou mal conservés avant utilisation
Utiliser des sérums frais obtenus après un prélèvement sanguin sur tube sec (jusqu'à 7 jours de conservation à 2-8°C ou à -20°C pour une conservation supérieure à 7 jours), et ne présentant ni hémolyse, ni trouble, ni ictère, ni contamination.
OTHER
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 France; available across 12 countries total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary placement | — | Still on market |
| Czechia | — | Still on market |
| Germany | — | Still on market |
| EL | — | Still on market |
| Spain | — | Still on market |
| Croatia | — | Still on market |
| Hungary | — | Still on market |
| Italy | — | Still on market |
| Latvia | — | Still on market |
| Netherlands | — | Still on market |
| Portugal | — | Still on market |
| Türkiye | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
03661540101021Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
3661540PARhemag027E5248UDI 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.
W0105050204ECHINOCOCCUSPrimary 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.
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.