- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 9, 2026
B-06976202763248hLH Ovulation Rapid Test Midstream 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.
06976202763248GHhLH-103CN-MF-000032462(01)06976202763248
1 warning recorded — scroll inside the panel to see all entries.
CW010Sterile
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 Italy; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| ItalyPrimary placement | — | Still on market |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160304LH - RT & POCPrimary 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 →B-06976202763309On the marketHEV IgM Rapid TestB-06976202762500On the markethLH Ovulation Rapid TestB-06976202762012On the marketHSV 1/2 IgG Rapid TestB-06976202763125On the marketHSV 1/2 IgG/IgM Combo Rapid TestB-06976202763149On the marketHSV 1/2 IgG/IgM Rapid TestB-06976202763156On 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 →No certificate specifically references this device's Basic UDI-DI.