- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 26, 2026
B-06976202762937Leptospira IgG/IgM Rapid Test is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Zhejiang Greylynx Biotech Co., Ltd.. Placed on the EU market in Italy. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06976202762937GILEPb-402(01)06976202762937
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090199BACTERIOLOGY - RT & POC - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW010CN-MF-000032462Primary placement in Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
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.
B-06976202763187On the marketLegionella Pneumophila Rapid TestB-06976202763323On the marketLegionella Rapid TestB-06976202762197On the marketLyme IgG/IgM Rapid TestB-06976202763194On the marketLysergic Acid Diethylamide (LSD) Rapid TestB-06976202761190On the marketMalaria P.f. Rapid TestB-06976202762715On the marketCertificate health across this manufacturer's portfolio.
HX 2566030-1IssuedIX 2566030-1IssuedNotified 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 →