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IL-MF-0000266123902998CE013902998TD01HemoScreen is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Pixcell Medical Ltd.. Placed on the EU market in Denmark. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 28, 2025
7290016991HemoScreen200UWPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)07290016991000
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
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 Denmark; available across 17 countries total.
| Country | On market since | Until |
|---|---|---|
| DenmarkPrimary placement | Jan 1, 2021 | Still on market |
| Belgium | Apr 1, 2025 | Still on market |
| Czechia | Jan 1, 2023 | Still on market |
| Germany | Jan 1, 2023 | Still on market |
| EL | Jan 1, 2023 | Still on market |
| Spain | Oct 1, 2023 | Still on market |
| Finland | Jan 1, 2021 | Still on market |
| France | Jan 1, 2021 | Still on market |
| Ireland | Jan 1, 2023 | Still on market |
| Italy | Jan 1, 2023 | Still on market |
| Luxembourg | Apr 1, 2025 | Still on market |
| Netherlands | Jan 1, 2023 | Still on market |
| Poland | Jan 1, 2024 | Still on market |
| Portugal | Oct 1, 2023 | Still on market |
| Romania | May 1, 2025 | Still on market |
| Sweden | Jan 1, 2021 | Still on market |
| Slovakia | Jan 1, 2023 | 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.
07290016991000Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
7290016991HemoScreen200UWHS-FA-30219UDI 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.
W0202010101AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr)Certificate health across this manufacturer's portfolio.
3902998CE01Issued3902998TD01IssuedNotified 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 →Notified 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 →