- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on Jun 16, 2026
6970493090506006P3Serum Amyloid A Protein Calibrator is an EU IVDR-regulated in vitro diagnostic registered in EUDAMED. It is classified as IVDR Class C. 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.
06970493098409MY-0005-01CN-MF-000024842(01)06970493098409
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
1 warning recorded — scroll inside the panel to see all entries.
CW011Sterile
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.
W0102152203SPECIFIC PROTEIN STANDARDS AND CALIBRATORSPrimary 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 →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.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
697049309W02020000001A2On the marketSerum Amyloid A Protein CalibratorB-06970493098874On the marketSerum Amyloid A Protein CalibratorB-06970493098409On the marketSerum Amyloid A Protein CalibratorB-06970493098416On the marketSerum Amyloid A Protein CalibratorB-06970493098904On the marketSerum Amyloid A Protein CalibratorB-06970493098898On the market