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EUDAMED last updated this device on Apr 8, 2026
B-06977698402345Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →DOA Rapid Urine Test Device Strip/Cassette/Panel(Colloidal Gold ) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Dezhou Guoke Medical Technology Co., Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
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 →06977698402345Basic 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 →B-06977698402345GKPD043UDI 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 →(01)06977698402345
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105010801MYCOPLASMA ANTIGEN DETECTION1 warning recorded — scroll inside the panel to see all entries.
CW011Sterile
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 →No certificate specifically references this device's Basic UDI-DI.
Primary placement in Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | May 27, 2024 | May 26, 2029 |
CN-MF-000044128No 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.B-GKPD116XDOn the marketDigital Fertility Testing SystemB-06977698403663On the marketDOA Rapid Urine Test Device Cup(Colloidal Gold )B-06977698403618On the marketDry Fluorescence Immunoassay Analyzer697769840GKPD0166EOn the marketE2 Detection Kit (Immunofluorescence Chromatography)B-GKPD175XVOn the marketEnterovirus 71 (EV71) and Coxsackievirus A16 (CA16) Antigen Combo Rapid Test KitB-GKPD128XLOn the market