- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 7, 2026
B-06974735360170KEYU Hemoglobin Quality Control (Quantitative) is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Zhuhai Keyu Biological Engineering Co., Ltd. Placed on the EU market in Spain. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
CN-MF-000023195(01)06974735360170
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 Spain; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| SpainPrimary placement | — | Still on market |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
06974735360170Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-06974735360170FOB-QC-4UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102152099CONTROLS- IMMUNOCHEMISTRY - 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 →No certificate specifically references this device's Basic UDI-DI.
B-06974735360781On the marketKEYU H. Pylori Rapid Test Kit (Colloidal gold method)B-06974735360415On the marketKEYU H. Pylori Rapid Test Kit (Colloidal gold method)B-06974735360644On the marketKEYU Hemoglobin Quality Control (Quantitative)B-06974735361924On the marketKEYU Lactoferrin (LF) Test Kit (Colloidal Gold)B-06974735360613On the marketKEYU Lactoferrin (LF) Test Kit (Colloidal Gold)B-06974735360750On 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.