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EUDAMED last updated this device on Jun 12, 2026
69360201528XSingclean® is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class B. Manufactured by Hangzhou Singclean Medical Products Co., Ltd.. Placed on the EU market in France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06936020140423M90-02-25t(01)06936020140423
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102090199DRUGS OF ABUSE - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW010CN-MF-000014098The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in France; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| FrancePrimary 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 certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
V13 097027 0013IssuedNotified 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.
MDR.2292-2026/0024IssuedNotified 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.
MDR.2292-2026/0023IssuedNotified 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.
C544401IssuedNotified 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.
C637543IssuedNotified 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.
C544578IssuedNotified 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 →