- Role
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- Date of registration
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EUDAMED last updated this device on Jun 9, 2026
88001117IPAA01MA02W4Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →STANDARD™ M10 Calibration Kit is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by SD Biosensor Inc.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →08800111711350Basic 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 →88001117IPAA01MA02W4M10-CAL-01/11CAL10HUDI 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 →(01)08800111711350
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0101050302CALIBRATORS SINGLE COMPONENT (CC)3 warnings recorded — scroll inside the panel to see all entries.
CW010CW009CW007Sterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Italy; available across 22 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | May 11, 2023 | Still on market |
| Austria | May 11, 2023 | Still on market |
| Belgium | May 11, 2023 | Still on market |
| Germany | May 11, 2023 | Still on market |
| Denmark | May 11, 2023 | Still on market |
| Estonia | May 11, 2023 | Still on market |
| EL | May 11, 2023 | Still on market |
| Spain | May 11, 2023 | Still on market |
| Finland | May 11, 2023 | Still on market |
| France | May 11, 2023 | Still on market |
| Ireland | May 11, 2023 | Still on market |
| Lithuania | May 11, 2023 | Still on market |
| Latvia | May 11, 2023 | Still on market |
| Malta | May 11, 2023 | Still on market |
| Netherlands | May 11, 2023 | Still on market |
| Norway | May 11, 2023 | Still on market |
| Poland | May 11, 2023 | Still on market |
| Portugal | May 11, 2023 | Still on market |
| Romania | May 11, 2023 | Still on market |
| Sweden | May 11, 2023 | Still on market |
| Slovakia | May 11, 2023 | Still on market |
| Türkiye | May 11, 2023 | Still on market |
KR-MF-000009168Certificate health across this manufacturer's portfolio.
V13 075369 0072SupplementedNotified 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.
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