- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Dec 27, 2025
B-06936020115001FASUAL 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 France. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06936020115001/(01)06936020115001
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. For professional In Vitro diagnostic use only.Do not use after expiration date.2. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.3. Do not use it if the tube/pouch is damaged or broken.4. Test is for single use only. Do not re-use under any circumstances.5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens. 6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed. 7.Humidity and temperature can adversely affect results. 8. Do not perform the test in a room with strong air flow, ie. electric fan or strong air-conditioning."
Primary placement in France; available across 1 country total.
Placed on the market in France; per-country availability dates not published.
CN-MF-000014098Sterile
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.