- Role
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- Date of registration
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EUDAMED last updated this device on Jun 2, 2026
B-06970493092858Serum Amyloid A Protein Control is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Shenzhen Dymind Biotechnology Co., Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06970493092858MY-0006-03CN-MF-000024842(01)06970493092858
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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 Germany; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jun 26, 2024 | Dec 31, 2099 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102152003SPECIFIC PROTEIN CONTROLSPrimary 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-06970493098430On the marketSerum Amyloid A Protein CalibratorB-06970493098423On the marketSerum Amyloid A Protein ControlB-06970493098928On the marketSerum Amyloid A Protein Control6970493090506005NZOn the marketSerum Amyloid A Protein ControlB-06970493098911On the marketSerum Amyloid A Protein Reagent (Immunonephelometric Method)B-06970493098997On the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
HX 2183501-1IssuedNotified 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.
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