- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Sep 1, 2022
B-06974473305853MTHP Rapid Test Kit (Colloidal gold method) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Nanjing Synthgene Medical Technology Co., Ltd. . Placed on the EU market in Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06974473305853DP016CN-MF-000023810(01)06974473305853
2 warnings recorded — scroll inside the panel to see all entries.
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.
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 Netherlands; available across 1 country total.
Placed on the market in Netherlands; per-country availability dates not published.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102090199DRUGS OF ABUSE - OTHERPrimary 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.
B-06974473301596On the marketMQL Rapid Test Kit (Colloidal gold method)B-06974473301701On the marketMTD Rapid Test Kit (Colloidal gold method)B-06974473303149On the marketMyo Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)B-06974473308991On the marketNeisseria Gonorrhoeae Antigen Rapid Test Kit (Colloidal gold method)B-06974473306782On the marketNT-proBNP Rapid Test Kit (Quantum Dot Fluorescence Immunoassay)B-06974473302746On the marketNo certificates registered for this manufacturer.
No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.