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EUDAMED last updated this device on Dec 29, 2025
697015090000255HKAutoLumo sIgE Calibrators is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Autobio Diagnostics Co., Ltd.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06942359547345CA010301(01)06942359547345
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102152299STANDARDS AND CALIBRATORS - IMMUNOCHEMISTRY - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW010CN-MF-000003348The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Italy; available across 2 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
| Türkiye | — | 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 →Certificate health across this manufacturer's portfolio.
V10 071134 0020SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →69422530000131NEOn the marketAutoChem ISE Diluent69422530000131NEOn the marketAutoLumo FSH Calibrators697015090000027H4On the marketAutoLumo sIgE Calibrators697015090000255HKOn the marketAutoLumo sIgE Calibrators697015090000255HKOn the marketCalcitonin CLIA Microparticles697015090000048HCOn the marketNo certificate specifically references this device's Basic UDI-DI.