- Role
- Country
- Date of registration
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EUDAMED last updated this device on Apr 13, 2026
B-08033650846812ALKALINE PHOSPHATASE FL IFCC is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Chema Diagnostica Srl. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
IT-MF-000009128No 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.(01)08033650846812
3 warnings recorded — scroll inside the panel to see all entries.
CW084CW082CW132Sterile
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 Italy; available across 8 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | Still on market | |
| Belgium | Still on market | |
| Spain | Still on market | |
| Finland | Still on market | |
| France | Still on market | |
| Ireland | Still on market | |
| Luxembourg | Still on market | |
| Netherlands | 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.
08033650846812Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-08033650846812AF 6U420 BDUDI 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.
W01010105ALKALINE PHOSPHATASE - TOTALPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →B-08033650840506On the marketALKALINE PHOSPHATASE FL DGKCB-08033650840483On the marketALKALINE PHOSPHATASE FL IFCCB-08033650840520On the marketALKALINE PHOSPHATASE FL IFCCB-08033650840537On the marketALKALINE PHOSPHATASE FL IFCCB-08033650844986On the marketALKALINE PHOSPHATASE FL IFCCB-08033650845228On the marketNo certificate specifically references this device's Basic UDI-DI.