- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED data as of Aug 14, 2026
EUDAMED last updated this device on May 8, 2023
6973315739566BNQuantum Dot Fluorescence Immune Analyzer is an EU IVDR-regulated in vitro diagnostic on the European market. It is classified as IVDR Class A. Manufactured by Nanjing Vazyme Medical Technology Co.,Ltd.. Placed on the EU market in Germany. Explore certificates, regulatory status and the official record on MD Atlas.
06973315739566QD-S600CN-MF-000031032(01)06973315739566
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.
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.
Placed on the market in Germany; per-country availability dates not published.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0201020101AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h)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 →B-06973315739306On the marketQuality Control Kit for Logilet Respiratory Pathogen PanelB-06973315734875On the marketQuality Control Kit for Logilet STl PanelB-06973315739382On the marketReal-Time Fluorescence Quantitative PCR System6973315738446B4On the marketReal-Time Quantitative Thermal Cycler6973315739740BEOn the marketSample Preservation Buffer6973315734820AAOn the marketNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
EU-TDA-FI-66922-800033-2025IssuedEU-QMS-FI-01219-800033-2025IssuedNotified 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.
Notified 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.