- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Mar 25, 2026
697052264SJMYX0005XASystem Check Solution is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class A. Manufactured by Sichuan Orienter Biotechnology Co., Ltd.. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06970522648483QC1501(01)06970522648483
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0599IVD GENERAL USE CONSUMABLE DEVICES - OTHER1 warning recorded — scroll inside the panel to see all entries.
CW010CN-MF-000003026The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
Primary placement in Spain; available across 1 country total.
Placed on the market in Spain; per-country availability dates not published.
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 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.No certificate specifically references this device's Basic UDI-DI.
697052264SJMYX0003X6On the marketSoluble Growth Stimulation Expressed Gene 2 (ST2) Assay Kit (Chemiluminescent Immunoassay)B-06942028504778On the marketSquamous Cell Carcinoma Antigen (SCC) Assay Kit (Chemiluminescent Immunoassay)B-06970522642382On the markett-PAIC Assay Kit(Chemiluminescent Immunoassay)B-06942028501722On the marketTestosterone (T) Assay Kit (Chemiluminescent Immunoassay)B-06970522649510On the marketThe MB Isoenzyme of Creatine Kinase (CK-MB) Assay Kit (Chemiluminescent Immunoassay)B-06970522645994On the market