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EUDAMED last updated this device on Nov 28, 2025
++G322G3220013G9A1ITKENNOLIFE Comprehensive Plus Panel is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. Manufactured by ProtectLife International Biomedical Inc.. Placed on the EU market in Romania. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
++G3220013G9A001-3G9A++G3220013G9A
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101060109MULTIPLE PARAMETER BLOOD TESTTW-MF-000039217Primary placement in Romania; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| RomaniaPrimary 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 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.++G322G322001256D16KZOn the marketENNOLIFE Clinical Chemistry Analyzer (Non-sterile)++G322G322HCATE300MQQ8On the marketENNOLIFE Comprehensive II Panel++G322G3220013H9C1LUEOn the marketENNOLIFE HbA1c Disc++G322G322001218BL8MBOn the marketENNOLIFE HDL Cholesterol Kit (Non-sterile)++G322G322001218A11JAOn the marketENNOLIFE Kidney Panel++G322G322001246E16KTOn the marketNo certificate specifically references this device's Basic UDI-DI.