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KR-MF-000009168STANDARD™ M10 STI Sample Pretreatment 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.
EUDAMED last updated this device on Jun 2, 2026
88001117IPAA01MA12W7Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)08800111719219
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.
CW009Sterile
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 24 countries total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | May 30, 2023 | Still on market |
| Austria | May 30, 2023 | Still on market |
| Bulgaria | May 30, 2023 | Still on market |
| Germany | May 30, 2023 | Still on market |
| Denmark | May 30, 2023 | Still on market |
| Estonia | May 30, 2023 | Still on market |
| EL | May 30, 2023 | Still on market |
| Spain | May 30, 2023 | Still on market |
| Finland | May 30, 2023 | Still on market |
| France | May 30, 2023 | Still on market |
| Croatia | May 30, 2023 | Still on market |
| Ireland | May 30, 2023 | Still on market |
| Lithuania | May 30, 2023 | Still on market |
| Latvia | May 30, 2023 | Still on market |
| Malta | May 30, 2023 | Still on market |
| Netherlands | May 30, 2023 | Still on market |
| Norway | May 30, 2023 | Still on market |
| Poland | May 30, 2023 | Still on market |
| Portugal | May 30, 2023 | Still on market |
| Romania | May 30, 2023 | Still on market |
| Sweden | May 30, 2023 | Still on market |
| Slovenia | May 30, 2023 | Still on market |
| Slovakia | May 30, 2023 | Still on market |
| Türkiye | May 30, 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.
08800111719219Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
88001117IPAA01MA12W7M10-STIP-01UDI 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.
W0580IVD GENERAL USE CONSUMABLES DEVICES - OTHER ACCESSORIESCertificate health across this manufacturer's portfolio.
V76 075369 0075IssuedV13 075369 0072SupplementedV74 075369 0070RestrictedV76 075369 0071IssuedNotified 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 →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 →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 →No certificate specifically references this device's Basic UDI-DI.