- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 11, 2026
B-00816426020085K-ASSAY Complement C4 is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by KAMIYA BIOMEDICAL COMPANY, LLC. Placed on the EU market in Czechia. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
00816426020085KAI-010(01)00816426020085
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102010205COMPLEMENT COMPONENT C4US-MF-000002769Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Primary placement in Czechia; available across 3 countries total.
| Country | On market since | Until |
|---|---|---|
| CzechiaPrimary placement | — | Still on market |
| Germany | — | Still on market |
| EL | — | 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 →B-00816426021303On the marketK-ASSAY Beta-2 Microglobulin/Ferritin - Serum/Plasma ControlB-00816426021327On the marketK-ASSAY Complement C3B-00816426020078On the marketK-ASSAY CRPB-00816426020184On the marketK-ASSAY CRP (3)B-00816426020344On the marketK-ASSAY CRP (Ver.2)B-00816426021549On 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.No certificate specifically references this device's Basic UDI-DI.