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EUDAMED last updated this device on Dec 27, 2025
B-06936020116367Singclean® 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.
06936020116367IVD64-02-1t(01)06936020116367
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105041199OTHER CORONAVIRUS REAGENTS1 warning recorded — scroll inside the panel to see all entries.
1. For professional In Vitro diagnostic use only.Do not use after expiration date.2. These instructions must be strictly followed by a trained healthcare professional to achieve accurateresults. All users have to read the instruction prior to performing a test. 3.Do not use it if the tube/pouch is damaged or broken. 4. Wear protective gloves while handling specimens and wash hands thoroughly afterwards. 5.Avoid splashing or aerosol formation of specimen and buffer. 6.Clean up spills thoroughly using an appropriate disinfectant.7. Decontaminate and dispose of all specimens, reaction kits and potentially contaminated materials (such as dropper, lancets, sterilizing tablet, test cassette) in a biohazard container as if they wereinfectious waste and dispose according to applicable local regulations. 8.Do not mix or interchange different specimens. 9. Do not mix reagent of different lots or those for other products. 10.Do not store the test kit in direct sunlight. 11. To avoid cross-contamination, do not reuse the dropper, lancets, sterilizing tablet and test cassette. 12. Do not use with any solution except for the provided extraction buffer. 13. Test is for single use only. Do not re-use under any circumstances. 14. Do not perform the test in a room with strong air flow, such as electric fan or strong air-conditioning.
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 →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.2292-2026/0023IssuedNotified 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.
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.
V74 097027 0010IssuedNotified 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.
V74 097027 0007SupplementedNotified 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.
View in glossary →No certificate specifically references this device's Basic UDI-DI.