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EUDAMED last updated this device on Dec 27, 2025
B-06936020111690Singclean® is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Hangzhou Singclean Medical Products Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06936020111690IVD49-02-1t(01)06936020111690
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105041101CORONAVIRUS AG1 warning recorded — scroll inside the panel to see all entries.
1.Use fresh samples whenever possible.2. Optimal assay performance requires strict adherence to the assay procedure described in this insert sheet.Deviations may lead to aberrant results.3. A negative result for an individual subject indicates absence of detectable COVID-19 (SARS-CoV-2) antigen.However, a negative test result does not preclude the possibility of exposure to or infection with COVID-19.4. A negative result can occur if the quantity of the COVlD-19 (SARS-CoV-2) antigen present in the specimen is below the detection limits of the assay, or failed to collect the COVID-19 (SARS-COV-2) antigen in the nasal cavityof the patient.5. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.
CN-MF-000014098Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
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 0013IssuedMDR.2292-2026/0023IssuedMDR.2292-2026/0024IssuedV74 097027 0010IssuedV74 097027 0007SupplementedC544401IssuedNotified 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.
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 →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 →